A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

• ClinicalTrials.gov Identifier: NCT02505334
• Recruitment Status: Completed
• First Posted: July 22, 2015
• Results First Posted: June 25, 2018
• Last Update Posted: September 5, 2018
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.

Condition or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: liraglutide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 635 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus
• Actual Study Start Date: July 21, 2015
• Actual Primary Completion Date: May 2, 2017
• Actual Study Completion Date: November 9, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Liraglutide 1.8 mg; The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.	Drug: liraglutide; Injected subcutaneously s.c. (under the skin) once daily.
Active Comparator: Liraglutide 0.9 mg; The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.	Drug: liraglutide; Injected subcutaneously s.c. (under the skin) once daily.

Outcome Measures

Primary Outcome Measures :

1. Change in Glycosylated Haemoglobin (HbA1c) (Week 26) [ Time Frame: Week 0, Week 26 ]
   Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.

Secondary Outcome Measures :

1. Change in HbA1c (Week 52) [ Time Frame: Week 0, Week 52 ]
   Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
2. Responder for HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 and Week 52 ]
   Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
3. Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 and Week 52 ]
   Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.
4. Responder for HbA1c Below 7.0% Without Weight Gain [ Time Frame: Week 26 and Week 52 ]
   Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.
5. Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Week 26 and Week 52 ]
   Reported results are subjects with HbA1c <7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'
6. Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile) [ Time Frame: Week 0 and Week 26 and Week 52 ]

   Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:

   1. Before breakfast.
   2. 90 minutes after start of breakfast.
   3. Before lunch.
   4. 90 minutes after start of lunch.
   5. Before dinner.
   6. 90 minutes after start of dinner.
   7. At bedtime.
7. Change in SMBG 7-point Profile: Mean of 7-point Profile [ Time Frame: Week 0, Week 26, Week 52 ]
   Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
8. Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner) [ Time Frame: Week 0, Week 26, Week 52 ]
   Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
9. Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26, Week 52 ]
   Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
10. Change in Waist Circumference [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
11. Change in Body Weight [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
12. Change in Body Mass Index (BMI) [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
13. Change in Blood Pressure (Systolic and Diastolic) [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
14. Fasting C-peptide [ Time Frame: Week 26 and Week 52 ]
    Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
15. Fasting Insulin [ Time Frame: Week 26 and Week 52 ]
    Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
16. Fasting Glucagon [ Time Frame: Week 26 and Week 52 ]
    Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
17. Proinsulin [ Time Frame: Week 26 and Week 52 ]
    Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
18. Proinsulin/Insulin [ Time Frame: Week 26 and Week 52 ]
    Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
19. Homeostasis Model Assessment of Beta-cell Function (HOMA-B) [ Time Frame: Week 26 and Week 52 ]
    HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)].
20. Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) [ Time Frame: Week 26 and Week 52 ]
    HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.
21. Total Cholesterol [ Time Frame: Week 26 and Week 52 ]
    Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
22. Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Week 26 and Week 52 ]
    LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
23. High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Week 26 and Week 52 ]
    HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
24. Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Week 26 and Week 52 ]
    VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
25. Triglycerides [ Time Frame: Week 26 and Week 52 ]
    Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
26. Free Fatty Acids [ Time Frame: Week 26 and Week 52 ]
    Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
27. Number of Treatment Emergent Adverse Events [ Time Frame: Weeks 0-26 and Weeks 0-52 ]
    Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.
28. Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 and Weeks 0-52 ]
    Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.
29. Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 and Weeks 0-52 ]
    Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
30. Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition [ Time Frame: Weeks 0-26 and Weeks 0-52 ]

    American Diabetes Association (ADA) classification of hypoglycaemia:

    1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
    2. Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.
    3. Asymptomatic: PG level ≤3.9 mmol/L without symptoms.
    4. Probable symptomatic: No measurement with symptoms.
    5. Pseudo: PG level >3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
31. Change in Pulse [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
32. Change in Physical Examination [ Time Frame: Week 0 and Week 26 and Week 52 ]

    Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).

    1. Cardiovascular system
    2. Central and peripheral nervous system (PNS)
    3. Gastrointestinal (GI) system including mouth
    4. General appearance
    5. Head, ears, eyes, nose, throat, neck
    6. Lymph node palpation
    7. Musculoskeletal system
    8. Respiratory system
    9. Skin
    10. Thyroid gland
33. Change in Eye Examination [ Time Frame: Week 0 and Week 26 and Week 52 ]
    Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
34. Change in Electrocardiogram (ECG) [ Time Frame: Week 0 and Week 26 and Week 52 ]
    Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
35. Change in Biochemistry: Creatinine [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
36. Change in Biochemistry: eGFR [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m^2.
37. Change in Biochemistry: Alanine Aminotransferase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
38. Change in Biochemistry: Aspartate Aminotransferase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
39. Change in Biochemistry: Alkaline Phosphatase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
40. Change in Biochemistry: Sodium [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
41. Change in Biochemistry: Potassium [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
42. Change in Biochemistry: Albumin [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
43. Change in Biochemistry: Total Bilirubin [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
44. Change in Biochemistry: Urea [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
45. Change in Biochemistry: Creatine Kinase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
46. Change in Biochemistry: Calcium [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
47. Change in Biochemistry: Albumin Corrected Calcium [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
48. Change in Biochemistry: Amylase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
49. Change in Biochemistry: Lipase [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
50. Change in Haematology: Haemoglobin [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
51. Change in Haematology: Haematocrit [ Time Frame: Week 0, Week 26, Week 52 ]
    Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.
52. Change in Haematology: Thrombocytes [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
53. Change in Haematology: Erythrocytes [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
54. Change in Haematology: Leukocytes [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
55. Change in Haematology: Eosinophils [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
56. Change in Haematology: Neutrophils [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
57. Change in Haematology: Basophils [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
58. Change in Haematology: Monocytes [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
59. Change in Haematology: Lymphocytes [ Time Frame: Week 0, Week 26 and Week 52 ]
    Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
60. Change in Calcitonin [ Time Frame: Week 0 and Week 26 and Week 52 ]
    Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female Japanese subjects at least 20 years of age at the time of informed consent
• Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
• HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)
• Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion Criteria:

• Treatment with insulin within 12 weeks prior to screening
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
• Screening calcitonin equal or above 50 ng/l
• History of pancreatitis (acute or chronic)
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
• Subjects presently classified as being in New York Heart Association (NYHA) Class IV
• Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
• Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
• Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

Contacts and Locations

Locations

Japan

Novo Nordisk Investigational Site

Annaka-shi, Gunma, Japan, 379 0116

Novo Nordisk Investigational Site

Chitose, Hokkaido, Japan, 066-0032

Novo Nordisk Investigational Site

Chuo-ku Tokyo, Japan, 103-0027

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, Japan, 103 0002

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, Japan, 103 0027

Novo Nordisk Investigational Site

Chuo-ku,, Japan, 104 0061

Novo Nordisk Investigational Site

Fukuoka-shi, Fukuoka, Japan

Novo Nordisk Investigational Site

Higashiosaka-shi, Osaka, Japan

Novo Nordisk Investigational Site

Hokkaido, Japan, 078-8236

Novo Nordisk Investigational Site

Ichikawa-shi, Chiba, Japan

Novo Nordisk Investigational Site

Iruma-shi, Saitama, Japan, 358 0011

Novo Nordisk Investigational Site

Izumisano-shi, Japan, 598 0048

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, Japan, 582 0005

Novo Nordisk Investigational Site

Kawagoe-shi, Saitama, Japan, 350 0851

Novo Nordisk Investigational Site

Kobe-shi, Hyogo, Japan

Novo Nordisk Investigational Site

Kumamoto-shi,Kumamoto, Japan, 862 0976

Novo Nordisk Investigational Site

Mito-shi, Ibaraki, Japan, 310-0845

Novo Nordisk Investigational Site

Mito-shi, Ibaraki, Japan

Novo Nordisk Investigational Site

Miyazaki-shi, Japan, 880 0034

Novo Nordisk Investigational Site

Naka-shi, Ibaraki, Japan, 311 0113

Novo Nordisk Investigational Site

Neyagawa-shi, Osaka, Japan

Novo Nordisk Investigational Site

Nishinomiya-shi, Hygo, Japan, 662 0971

Novo Nordisk Investigational Site

Nishinomiya-shi, Hyogo, Japan, 663-8501

Novo Nordisk Investigational Site

Oita-shi, Japan, 870 0039

Novo Nordisk Investigational Site

Okawa-shi, Fukuoka, Japan, 831 0016

Novo Nordisk Investigational Site

Osaka-shi, Osaka, Japan, 553 0003

Novo Nordisk Investigational Site

Osaka-shi, Osaka, Japan, 5590012

Novo Nordisk Investigational Site

Oyama-shi, Tochigi, Japan, 323 0022

Novo Nordisk Investigational Site

Saga-shi,Saga, Japan, 849 0937

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, Japan, 060 0062

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, Japan, 060-0001

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, Japan, 062 0007

Novo Nordisk Investigational Site

Sappro-shi, Hokkaido, Japan, 060 8648

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, Japan, 329 0433

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, Japan, 160-0008

Novo Nordisk Investigational Site

Shizuoka-shi, Japan, 424 0853

Novo Nordisk Investigational Site

Suita-shi, Osaka, Japan, 565-0853

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, Japan, 569 1096

Novo Nordisk Investigational Site

Tokyo, Japan, 103-0028

Novo Nordisk Investigational Site

Tokyo, Japan, 105-8471

Novo Nordisk Investigational Site

Tokyo, Japan, 123-0845

Novo Nordisk Investigational Site

Tokyo, Japan, 144-0051

Novo Nordisk Investigational Site

Tokyo, Japan, 169-0073

Novo Nordisk Investigational Site

Tokyo, Japan, 181-0013

Novo Nordisk Investigational Site

Yokohama, Kanagawa, Japan, 236-0004

Novo Nordisk Investigational Site

Yokohama-shi Kanagawa, Japan, 232-0064

Novo Nordisk Investigational Site

Yokohama-shi, Japan, 235 0045

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure 1452; Novo Nordisk A/S

  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:

Study Protocol  [PDF] April 10, 2018

Statistical Analysis Plan  [PDF] April 10, 2018

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02505334
• Other Study ID Numbers: NN2211-4174; U1111-1164-5462 ( Other Identifier: WHO ); JapicCTI-152975 ( Registry Identifier: JAPIC )
• First Posted: July 22, 2015
• Results First Posted: June 25, 2018
• Last Update Posted: September 5, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://www.novonordisk-trials.com/website/content/how-to-access-clinical-trial-datasets.aspx

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

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