Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin (SCALE™ Insulin)

• ClinicalTrials.gov Identifier: NCT02963922
• Recruitment Status: Completed
• First Posted: November 15, 2016
• Results First Posted: November 27, 2019
• Last Update Posted: March 30, 2020
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.

Condition or disease	Intervention/treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: Liraglutide 3.0 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 396 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
• Actual Study Start Date: February 6, 2017
• Actual Primary Completion Date: September 10, 2018
• Actual Study Completion Date: September 25, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: liraglutide 3.0 mg	Drug: Liraglutide 3.0 mg; Injected subcutaneously (s.c., under the skin) once daily
Placebo Comparator: Placebo	Drug: Placebo; Injected subcutaneously (s.c., under the skin) once daily

Outcome Measures

Primary Outcome Measures :

1. Change in Body Weight (%) [ Time Frame: Week 0, week 56 ]
   Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
2. Participants Losing at Least 5% of Baseline Body Weight [ Time Frame: Week 56 ]
   The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).

Secondary Outcome Measures :

1. Participants Losing More Than 10% of Baseline Body Weight at Week 56 [ Time Frame: Week 56 ]
   The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
2. Change in Waist Circumference [ Time Frame: Week 0, week 56 ]
   Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
3. Change in HbA1c [ Time Frame: Week 0, week 56 ]
   Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
4. Change in FPG [ Time Frame: Week 0, week 56 ]
   Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
5. Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score [ Time Frame: Week 0, week 56 ]
   SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline.
6. Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score [ Time Frame: Week 0, week 56 ]
   Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
7. Change in Total Daily Insulin Dose (U) [ Time Frame: Week 0, week 56 ]
   Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
8. Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) [ Time Frame: Week 0, week 56 ]
   Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
9. Change in Total Daily Basal Insulin Dose (U/kg) [ Time Frame: Week 0, week 56 ]
   Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
10. Change in Total Daily Insulin Dose (U/kg) [ Time Frame: Week 0, week 56 ]
    Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
11. Change in 7-point SMPG Profile Mean Daytime Glucose Value [ Time Frame: Week 0, week 56 ]
    Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner and at bedtime. Change from baseline (week 0) to week 56 in 7-point self-measured plasma glucose (SMPG) profile mean daytime glucose value was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
12. Change in sBP and dBP [ Time Frame: Week 0, week 56 ]
    Change in systolic blood pressure (sBP) and diastolic blood pressure (dBP) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
13. Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA [ Time Frame: Week 0, week 56 ]
    Change in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids (FFA) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
14. Change in SF-36: Sub-domains [ Time Frame: Week 0, week 56 ]
    SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores was presented based on in-trial data. A positive change score indicates an improvement since baseline. Results are presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
15. Change in SF-36: Physical Component Summary (PCS) [ Time Frame: Week 0, week 56 ]
    Change in short form 36 v2.0 acute domain physical component summary (PCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
16. Change in SF-36: Mental Component Summary (MCS) [ Time Frame: Week 0, week 56 ]
    Change in short form 36 v2.0 acute domain mental component summary (MCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
17. Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score [ Time Frame: Week 0, week 56 ]
    Change in IWQoL-Lite for CT pain and discomfort domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
18. Change in IWQoL-Lite for CT: Psychosocial Domain Score [ Time Frame: Week 0, week 56 ]
    Change in IWQoL-Lite for CT psychosocial domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
19. Change in IWQoL-Lite for CT: Total Score [ Time Frame: Week 0, week 56 ]
    Change in IWQoL-Lite for CT total score from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
20. Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses [ Time Frame: Week 0, week 56 ]
    The WRSS measure is a questionnaire under development. The version applied in this study has 10 items that measure the presence and bothersomeness of 10 weight-related symptoms. Each item has a categorical part with answers on the following 5 possible levels: 'Never/Almost never', 'Rarely', 'Sometimes', 'Often' and 'Almost always/Always'. Number of participants in each category at baseline (week 0) and week 56 was presented. Scoring algorithm was not available prior to database lock and therefore it was decided and documented in the statistical analysis plan that WRSS total score was not to be calculated and analyzed.
21. Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5% [ Time Frame: Week 56 ]
    Percentage of participants who achieved HbA1c <7% and weight loss ≥5% from baseline at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
22. Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia [ Time Frame: Week 56 ]
    Percentage of participants who achieved HbA1c <7%, weight loss ≥5% from baseline and no documented symptomatic hypoglycaemia at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
23. Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score [ Time Frame: Week 56 ]
    Percentage of participants who achieved ≥4.3 T-score points increase from baseline in SF-36 acute physical functioning score at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
24. Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS [ Time Frame: Week 56 ]
    Percentage of participants who achieved ≥3.8 T-score points increase from baseline in SF-36 acute PCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
25. Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS [ Time Frame: Week 56 ]
    Percentage of participants who achieved ≥4.6 T-score points increase from baseline in SF-36 acute MCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
26. Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score [ Time Frame: Week 56 ]
    Percentage of participants who achieve responder definition value for IWQoL-Lite for CT physical function domain score was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
27. Adverse Events (AEs) [ Time Frame: Week 0 to week 56 + 30 days ]
    An AE was defined as any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. Number of AEs from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on in-trial data was presented. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
28. Number of Hypoglycaemic Episodes [ Time Frame: Week 0 to week 56 + 30 days ]
    Number of hypoglycaemic episodes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
29. Change in Physical Examination [ Time Frame: Week -1, week 56 ]
    Physical examination parameters are categorised as abdomen; gastrointestinal system; cardiovascular system; central and peripheral nervous system; general appearance; head, eyes, ears, nose, throat (ENT) and neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -1) and week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
30. Change in Resting Pulse [ Time Frame: Week -1, week 56 ]
    Change from baseline (week -1) to week 56 in resting pulse was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
31. Change in Electrocardiogram (ECG) [ Time Frame: Week -1, week 56 ]
    The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 56 were presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
32. Change in Laboratory Measurements (Haematology) - Haemoglobin [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in haemoglobin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
33. Change in Laboratory Measurements (Haematology) - Haematocrit [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in Haematocrit was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
34. Change in Laboratory Measurements (Haematology) - Erythrocytes [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in erythrocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
35. Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in thrombocytes and leukocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
36. Change in Laboratory Parameters (Biochemistry) - Albumin [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in albumin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
37. Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
38. Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in bicarbonate, total calcium, potassium, sodium and urea was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
39. Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in total bilirubin and creatinine was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
40. Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in high sensitive C-reactive protein was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
41. Change in Laboratory Parameters (Biochemistry) - eGFR [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in estimated GFR serum using Modification of Diet in Renal Disease (MDRD) formula was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
42. Change in Laboratory Parameters (Biochemistry) - Uric Acid [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in uric acid was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
43. Change in Laboratory Parameters (Biochemistry) - Calcitonin [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in calcitonin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
44. Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone [ Time Frame: Week 0, week 56 ]
    Change from baseline (week 0) to week 56 in thyroid stimulating hormone was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Diagnosed with type 2 diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone, SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or above 27 kg/m^2 - Age at least 18 years at the time of signing informed consent Exclusion Criteria: - Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator - Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening - Treatment with a DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening - Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner - Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis (acute or chronic) - History of major depressive disorder within the past 2 years - Any lifetime history of a suicide attempt - Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Contacts and Locations

Locations

United States, Alabama

Novo Nordisk Investigational Site

Birmingham, Alabama, United States, 35294

United States, California

Novo Nordisk Investigational Site

Concord, California, United States, 94520

Novo Nordisk Investigational Site

Fresno, California, United States, 93720

United States, Florida

Novo Nordisk Investigational Site

Jacksonville, Florida, United States, 32205

Novo Nordisk Investigational Site

Plantation, Florida, United States, 33324

United States, Georgia

Novo Nordisk Investigational Site

Roswell, Georgia, United States, 30076

United States, Hawaii

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States, 96814

United States, Illinois

Novo Nordisk Investigational Site

Chicago, Illinois, United States, 60607

United States, Kentucky

Novo Nordisk Investigational Site

Louisville, Kentucky, United States, 40213

United States, Massachusetts

Novo Nordisk Investigational Site

North Dartmouth, Massachusetts, United States, 02747

United States, Minnesota

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States, 55416

United States, Montana

Novo Nordisk Investigational Site

Butte, Montana, United States, 59701

United States, New York

Novo Nordisk Investigational Site

Albany, New York, United States, 12206

United States, North Carolina

Novo Nordisk Investigational Site

Wilmington, North Carolina, United States, 28401

United States, Texas

Novo Nordisk Investigational Site

Austin, Texas, United States, 78731

Novo Nordisk Investigational Site

Austin, Texas, United States, 78749

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75230

Novo Nordisk Investigational Site

Dallas, Texas, United States, 75231

United States, Virginia

Novo Nordisk Investigational Site

Winchester, Virginia, United States, 22601-3834

Canada, Alberta

Novo Nordisk Investigational Site

Calgary, Alberta, Canada, T2V 4J2

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada, T6H 2L4

Canada, Nova Scotia

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada, B3H 2Y9

Canada, Ontario

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada, L8L 5G8

Novo Nordisk Investigational Site

London, Ontario, Canada, N6A 5B7

Novo Nordisk Investigational Site

Toronto, Ontario, Canada, M6G 1M2

Novo Nordisk Investigational Site

Waterloo, Ontario, Canada, N2J 1C4

Canada

Novo Nordisk Investigational Site

Quebec, Canada, G1V 4G5

Germany

Novo Nordisk Investigational Site

Dresden, Germany, 01307

Novo Nordisk Investigational Site

Essen, Germany, 45219

Novo Nordisk Investigational Site

Falkensee, Germany, 14612

Novo Nordisk Investigational Site

Hamburg, Germany, 22607

Novo Nordisk Investigational Site

Leipzig, Germany, 04103

Novo Nordisk Investigational Site

Münster, Germany, 48145

Novo Nordisk Investigational Site

Rehlingen-Siersburg, Germany, 66780

Novo Nordisk Investigational Site

Saint Ingbert-Oberwürzbach, Germany, 66386

Israel

Novo Nordisk Investigational Site

Haifa, Israel, 35152

Novo Nordisk Investigational Site

Jerusalem, Israel, 91120

Novo Nordisk Investigational Site

Kfar Saba, Israel, 44281

Novo Nordisk Investigational Site

Petah-Tikva, Israel, 49372

Novo Nordisk Investigational Site

Tel Hashomer, Israel, 52621

Novo Nordisk Investigational Site

Tel-Aviv, Israel, 64239

Italy

Novo Nordisk Investigational Site

Bologna, Italy, 40138

Novo Nordisk Investigational Site

Napoli, Italy, 80131

Novo Nordisk Investigational Site

Palermo, Italy, 90127

Novo Nordisk Investigational Site

Rome, Italy, 00168

Mexico

Novo Nordisk Investigational Site

Guadalajara, Jalisco, Mexico, 44600

Novo Nordisk Investigational Site

Monterrey, Nuevo León, Mexico, 64620

Turkey

Novo Nordisk Investigational Site

Ankara, Turkey, 06500

Novo Nordisk Investigational Site

Antalya, Turkey, 07058

Novo Nordisk Investigational Site

Istanbul, Turkey, 34096

Novo Nordisk Investigational Site

Istanbul, Turkey, 34303

Novo Nordisk Investigational Site

Istanbul, Turkey, 34371

Novo Nordisk Investigational Site

Istanbul, Turkey, 34890

Novo Nordisk Investigational Site

Izmir, Turkey, 35340

Sponsors and Collaborators

Novo Nordisk A/S

  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:

Study Protocol  [PDF] February 18, 2019

Statistical Analysis Plan  [PDF] February 18, 2019

More Information

Publications of Results:

Garvey WT, Birkenfeld AL, Dicker D, Mingrone G, Pedersen SD, Satylganova A, Skovgaard D, Sugimoto D, Jensen C, Mosenzon O. Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial. Diabetes Care. 2020 May;43(5):1085-1093. doi: 10.2337/dc19-1745. Epub 2020 Mar 5.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02963922
• Other Study ID Numbers: NN8022-4272; U1111-1177-4903 ( Other Identifier: World Health Organization (WHO) ); 2015-005619-33 ( EudraCT Number )
• First Posted: November 15, 2016
• Results First Posted: November 27, 2019
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Nutrition Disorders; Overnutrition; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liraglutide; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists