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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963922


Locations
Show Show 54 study locations
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

Publications of Results:
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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    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Nutrition Disorders
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists