A Study of a 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, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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)

306

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
      • Dimitrovgrad, Bulgaria, 6400
      • Pleven, Bulgaria, 5800
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
      • Varna, Bulgaria, 9010
      • Bad Lauterberg, Germany, 37431
      • Berlin, Germany, 10115
      • Görlitz, Germany, 02826
      • Hannover, Germany, 30167
      • Mainz, Germany, 55116
      • Neuss, Germany, 41460
      • Nürnberg, Germany, 90402
      • Guatemala City, Guatemala, 01015
      • Hong Kong, Hong Kong
      • Riga, Latvia, 1002
      • Kaunas, Lithuania, 51270
      • Klaipeda, Lithuania, 92304
      • Vilnius, Lithuania, 08661
      • Guadalajara, Mexico, 44340
      • Guadalajara, Mexico, 44650
      • Mexico City, Mexico, 03100
      • Mexico City, Mexico, 14080
      • Mexico City, Mexico, 11650
      • Mexico City, Mexico, 14610
      • Monterrey, Mexico, 64460
      • Pachuca, Mexico, 42086
      • Brasov, Romania, 500365
      • Bucharest, Romania
      • Bucharest, Romania, 020475
      • Bucharest, Romania, 050452
      • Cluj-napoca, Romania, 400006
      • Jud Covasna, Romania, 520064
      • Mures, Romania, 540011
      • Ploiesti, Romania, 100163
      • Satu Mare, Romania, 3900
      • Sibiu, Romania, 550245
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Georgia
      • Woodstock, Georgia, United States, 30189
    • Illinois
      • Chicago, Illinois, United States, 60607
      • Springfield, Illinois, United States, 62704-1433
    • New York
      • Rochester, New York, United States, 14609
    • Oregon
      • Portland, Oregon, United States, 97239
    • Texas
      • Dallas, Texas, United States, 75246
      • Midland, Texas, United States, 79707
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Richmond, Virginia, United States, 23249

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, with stable metformin treatment for >=3 months;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • 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.

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: 1
20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Experimental: 2
20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Experimental: 3
20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Experimental: 4
20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Experimental: 5
20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Placebo Comparator: 6
sc weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in HbAlc
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Time Frame: Week 8
Week 8
Changes in lipid profile
Time Frame: Week 8
Week 8
AEs, laboratory parameters, primary pharmacokinetic parameters
Time Frame: Throughout study
Throughout study

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

February 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 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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