A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

November 1, 2016 updated by: Hoffmann-La Roche

A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

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

  • China
      • Beijing, China, 100730
      • Beijing, China, 100853
      • Beijing, China, 10029
      • Beijng, China, 100700
      • Chengdu, China, 610041
      • Chongqing, China, 400010
      • Guangzhou, China, 510120
      • Hangzhou, China, 310003
      • Hefei, China, 230022
      • Nanjing, China, 210036
      • Nanjing, China, 210006
      • Nanning, China, 530021
      • Shanghai, China, 200080
      • Shi Jiazhuang, China, 050051
      • Tianjin, China, 201203
      • Tianjin (天津), China, 300052
  • Hong Kong
      • Hong Kong, Hong Kong
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
      • Daegu, Korea, Republic of, 705-717
      • Daegu, Korea, Republic of, 42472
      • Gyeonggi-do, Korea, Republic of, 443-380
      • Gyeonggi-do, Korea, Republic of, 463-712
      • Gyeonggi-do, Korea, Republic of, 410-773
      • Incheon, Korea, Republic of, 405-760
      • Kangwon-do, Korea, Republic of, 220-701
      • Kyounggi-do, Korea, Republic of, 420-717
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 130-702
      • Seoul, Korea, Republic of, 139-872
      • Seoul, Korea, Republic of, 135-720
      • Seoul, Korea, Republic of, 110-746
      • Seoul, Korea, Republic of, 134-701
      • Seoul, Korea, Republic of
  • Malaysia
      • Johor Bahru, Malaysia, 80200
      • Kelantan, Malaysia, 16150
      • Kuala Lumpur, Malaysia, 50603
      • Kuala Lumpur, Malaysia, 50586
      • Penang, Malaysia, 10450
      • Putrajaya, Malaysia, 62250
      • Selangor, Malaysia
  • Philippines
      • Cebu, Philippines, 6000
      • Iloilo, Philippines, 5000
      • Manila, Philippines, 1000
      • Manila, Philippines, 1357
      • Manila, Philippines, 1503
      • Pasig, Philippines, 1605
  • Taiwan
      • Chia-Yi City, Taiwan, 60002
      • Taichung, Taiwan, 404
      • Tainan, Taiwan, 710
      • Taipei, Taiwan, 00112
      • Taipei, Taiwan, 220
      • Taoyuan County, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
      • Nakhonratchasima, Thailand, 30000

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-75 years of age
  • type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening
  • HbA1c 7-10% at screening
  • body weight stable (+/-5%) for >/= 12 weeks prior to screening
  • fasting C-peptide >/=1ng/ml
  • treatment-naïve for insulin

Exclusion Criteria:

  • diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
  • acute metabolic diabetic complications or evidence of clinically significant diabetic complications
  • clinically symptomatic gastrointestinal disease
  • history of chronic pancreatitis or acute idiopathic pancreatitis
  • >3 episodes of severe hypoglycemia within 6 months prior to screening
  • miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
  • any treatment with exenatide, exendin analogues, GLP-1 or its analogues

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: 1
Drug: metformin
as prescribed
Drug: taspoglutide
10mg sc weekly, 24 (-52) weeks
Drug: taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Experimental: 2
Drug: metformin
as prescribed
Drug: taspoglutide
10mg sc weekly, 24 (-52) weeks
Drug: taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Active Comparator: 3
Drug: metformin
as prescribed
Drug: insulin glargine
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control assessed by HbA1c
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
Time Frame: week 24
week 24
Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
Time Frame: week 24
week 24
Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
Time Frame: throughout study, laboratory assessments weeks 12, 24, 32 and 52
throughout study, laboratory assessments weeks 12, 24, 32 and 52
Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values
Time Frame: week 24
week 24

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZC22565

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 metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe