A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

November 1, 2016 updated by: Hoffmann-La Roche

A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Study Overview

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

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

      • Adelaide, Australia, 5000
      • Camperdown, Australia, 2050
      • Besancon, France, 25030
      • Corbeil Essonnes, France, 91106
      • Narbonne, France, 11108
      • Paris, France, 75877
      • Poitiers, France, 86021
      • Berlin, Germany, 10115
      • München, Germany, 80636
      • Neuss, Germany, 41460
      • Chihuahua, Mexico, 31238
      • Culiacan, Mexico, 80020
      • Monterrey, Mexico, 64410
      • Tampico, Mexico, 89109
      • Lima, Peru, 31
      • Lima, Peru, 10
      • Lima, Peru, LIMA 29
      • Ponce, Puerto Rico, 00716
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
      • Hot Springs, Arkansas, United States, 71913
      • Jonesboro, Arkansas, United States, 72401
    • California
      • National City, California, United States, 91950
    • Florida
      • Jacksonville, Florida, United States, 32216
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
    • Maryland
      • Hyattsville, Maryland, United States, 20783
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103
    • Texas
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
    • Virginia
      • Richmond, Virginia, United States, 23294

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:

  • male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
  • type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
  • HbA1c >=7.0% and <=9.5% at screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • clinically significant gastrointestinal disease;
  • treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
  • use of weight-lowering medications in the last 3 months;
  • uncontrolled hypertension;
  • previous exposure to GLP-1 or GLP-1 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
sc weekly
sc weekly
Experimental: Taspoglutide 20mg
sc weekly
sc weekly
Experimental: Taspoglutide 20mg-30mg
sc weekly
sc weekly
Experimental: Taspoglutide 20mg-40mg
sc weekly
sc weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients withdrawn because of gastrointestinal effects
Time Frame: Week 9
Week 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.
Time Frame: Week 9
Week 9

Collaborators and Investigators

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

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.

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

April 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 17, 2007

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

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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