Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

January 11, 2018 updated by: Novo Nordisk A/S

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chuo-ku, Tokyo, Japan, 103 0002
        • Novo Nordisk Investigational Site
      • Ebina-shi, Japan, 243 0432
        • Novo Nordisk Investigational Site
      • Ebina-shi, Kanagawa, Japan, 243 0401
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582 0005
        • Novo Nordisk Investigational Site
      • Katsushika-ku, Tokyo, Japan, 125 0054
        • Novo Nordisk Investigational Site
      • Koriyama-shi, Fukushima, Japan, 963 8851
        • Novo Nordisk Investigational Site
      • Miyazaki-shi, Japan, 880 0034
        • Novo Nordisk Investigational Site
      • Naka-shi, Ibaraki, Japan, 311 0113
        • Novo Nordisk Investigational Site
      • Niigata-shi, Niigata, Japan, 950 1104
        • Novo Nordisk Investigational Site
      • Nishinomiya-shi, Hygo, Japan, 662 0971
        • 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
      • Ota-ku, Tokyo, Japan, 144 0035
        • Novo Nordisk Investigational Site
      • Oyama-shi, Tochigi, Japan, 323 0022
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060 0062
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 062 0007
        • Novo Nordisk Investigational Site
      • Sendai-shi, Japan, 980 0021
        • Novo Nordisk Investigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329 0433
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Japan, 424 0853
        • Novo Nordisk Investigational Site
      • Takatsuki-shi, Osaka, Japan, 569 1096
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 187 8510
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Japan, 235 0045
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
  • Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
  • Body Mass Index (BMI) below 45.0 kg/m^2

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
  • Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lira+Insulin
Drug: liraglutide
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Drug: insulin
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Placebo Comparator: Placebo+Insulin
Drug: insulin
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
Drug: placebo
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Time Frame: Week 0, Week 16
Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.
Week 0, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
Time Frame: Week 0, Week 36
Estimated mean change from baseline in HbA1c after 36 Weeks of treatment
Week 0, Week 36
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Time Frame: Week 0, Week 16
Estimated mean change from baseline in FPG after 16 Weeks of treatment.
Week 0, Week 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
Time Frame: Week 0, Week 36
Estimated mean change from baseline in FPG after 36 Weeks of treatment.
Week 0, Week 36
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
Time Frame: Week 0, Week 16
Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.
Week 0, Week 16
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
Time Frame: Week 0, Week 36
Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.
Week 0, Week 36
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
Time Frame: Week 0, Week 16
Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.
Week 0, Week 16
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
Time Frame: Week 0, Week 36
Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.
Week 0, Week 36
Change in Body Weight From Baseline to Week 16
Time Frame: Week 0, Week 16
Estimated mean change in body weight after 16 Weeks of treatment
Week 0, Week 16
Change in Body Weight From Baseline to Week 36
Time Frame: Week 0, Week 36
Estimated mean change in body weight after 36 Weeks of treatment
Week 0, Week 36
Number of Adverse Events (AEs)
Time Frame: Week 0 to Week 36 (inclusive)
An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Week 0 to Week 36 (inclusive)
Number of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to week 36 (inclusive)

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.

Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL).
Week 0 to week 36 (inclusive)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

March 27, 2013

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3925
  • U1111-1122-4320 (Other Identifier: WHO)
  • JapicCTI-121802 (Other Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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