A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
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.
1 other identifier
interventional
306
10 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Feb 2007
Shorter than P25 for phase_2 diabetes-mellitus-type-2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 2, 2016
November 1, 2016
9 months
January 17, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in HbAlc
Week 8
Secondary Outcomes (3)
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Week 8
Changes in lipid profile
Week 8
AEs, laboratory parameters, primary pharmacokinetic parameters
Throughout study
Study Arms (6)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Woodstock, Georgia, 30189, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Springfield, Illinois, 62704-1433, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Midland, Texas, 79707, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Adelaide, 5000, Australia
Unknown Facility
Camperdown, 2050, Australia
Unknown Facility
Dimitrovgrad, 6400, Bulgaria
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Rousse, 7002, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Unknown Facility
Varna, 9010, Bulgaria
Unknown Facility
Bad Lauterberg im Harz, 37431, Germany
Unknown Facility
Berlin, 10115, Germany
Unknown Facility
Görlitz, 02826, Germany
Unknown Facility
Hanover, 30167, Germany
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Mainz, 55116, Germany
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Neuss, 41460, Germany
Unknown Facility
Nuremberg, 90402, Germany
Unknown Facility
Guatemala City, 01015, Guatemala
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Riga, 1002, Latvia
Unknown Facility
Kaunas, 51270, Lithuania
Unknown Facility
Klaipėda, 92304, Lithuania
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Vilnius, 08661, Lithuania
Unknown Facility
Guadalajara, 44340, Mexico
Unknown Facility
Guadalajara, 44650, Mexico
Unknown Facility
Mexico City, 03100, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Mexico City, 14080, Mexico
Unknown Facility
Mexico City, 14610, Mexico
Unknown Facility
Monterrey, 64460, Mexico
Unknown Facility
Pachuca, 42086, Mexico
Unknown Facility
Brasov, 500365, Romania
Unknown Facility
Bucharest, 020475, Romania
Unknown Facility
Bucharest, 050452, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Cluj-Napoca, 400006, Romania
Unknown Facility
Jud Covasna, 520064, Romania
Unknown Facility
Mures, 540011, Romania
Unknown Facility
Ploieşti, 100163, Romania
Unknown Facility
Satu Mare, 3900, Romania
Unknown Facility
Sibiu, 550245, Romania
Related Publications (1)
Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.
PMID: 19366970DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11