Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

November 8, 2017 updated by: Novo Nordisk A/S

A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy

This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

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 0027
        • Novo Nordisk INvestigational Site
      • Chuo-ku, Tokyo, Japan, 103 0002
        • Novo Nordisk INvestigational Site
      • Ehime, Japan, Japan, 790 0067
        • Novo Nordisk INvestigational Site
      • Fukuoka, Japan, 812 0025
        • Novo Nordisk INvestigational Site
      • Fukuoka, Japan, 818 8502
        • Novo Nordisk INvestigational Site
      • Fukuoka, Japan, 820 8505
        • Novo Nordisk INvestigational Site
      • Fukuoka, Japan, Japan, 810 8798
        • Novo Nordisk INvestigational Site
      • Fukuoka-shi, Fukuoka, Japan, 815 8555
        • Novo Nordisk INvestigational Site
      • Kamagaya-shi, Chiba, Japan, 273 0121
        • Novo Nordisk INvestigational Site
      • Kashiwara-shi, Osaka, Japan, 582 0005
        • Novo Nordisk INvestigational Site
      • Kawagoe-shi, Saitama, Japan, 350 0851
        • Novo Nordisk INvestigational Site
      • Kitakyushu-shi, Fukuoka, Japan, 800 0252
        • Novo Nordisk INvestigational Site
      • Koriyama-shi, Fukushima, Japan, 963 8851
        • Novo Nordisk INvestigational Site
      • Kumamoto-shi,Kumamoto, Japan, 862 0976
        • Novo Nordisk INvestigational Site
      • Kurume-shi, Fukuoka, Japan, 839 0863
        • 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
      • Oita, Japan, 870 8511
        • Novo Nordisk INvestigational Site
      • Okawa-shi, Fukuoka, Japan, 831 0016
        • Novo Nordisk INvestigational Site
      • Osaka-shi, Osaka, Japan, 532 0003
        • Novo Nordisk INvestigational Site
      • Osaka-shi, Osaka, Japan, 545 8586
        • 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, 060-0001
        • Novo Nordisk INvestigational Site
      • Sapporo-shi, Hokkaido, Japan, 062 0007
        • Novo Nordisk INvestigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329 0433
        • Novo Nordisk INvestigational Site
      • Shizuoka-shi, Japan, 424 0853
        • Novo Nordisk INvestigational Site
      • Tagajo-shi, Japan, 985 0852
        • Novo Nordisk INvestigational Site
      • Takatsuki-shi, Osaka, Japan, 569 1096
        • Novo Nordisk INvestigational Site
      • Tochigi, Japan, 329 0498
        • Novo Nordisk INvestigational Site
      • Tokyo, Japan, 104 0044
        • Novo Nordisk INvestigational Site
      • Tokyo, Japan, 113 0031
        • Novo Nordisk INvestigational Site
      • Tokyo, Japan, 125 0054
        • Novo Nordisk INvestigational Site
      • Yamaguchi, Japan, 755 0067
        • 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
  • Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
  • Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
  • HbA1c between 7.0-10.0% (both inclusive)
  • Body Mass Index (BMI) below 40.0 kg/m^2
  • Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
  • Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion Criteria:

  • Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
  • Calcitonin above or equal to 160 pg/mL
  • Personal history of non-familial medullary thyroid carcinoma
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
  • Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide + an OAD therapy
Drug: liraglutide
0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
Active Comparator: Two OADs combination therapy
Drug: oral anti-diabetic drug
An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 52 + 7 days
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
Week 0 to Week 52 + 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 52
Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).
Week 0 to Week 52
Change in HbA1c From Baseline to Week 52
Time Frame: Week 0, week 52
Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Week 0, week 52
Change in FPG From Baseline to Week 52
Time Frame: Week 0, week 52
Estimated mean change from baseline in FPG after 52 Weeks of treatment
Week 0, week 52

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)

January 10, 2012

Primary Completion (Actual)

April 26, 2013

Study Completion (Actual)

April 26, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3924
  • U1111-1121-3457 (Other Identifier: WHO)
  • JapicCTI-121744 (Registry 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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe