- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00423501
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
Status
Completed
Conditions
Intervention / Treatment
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
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Adelaide, Australia, 5000
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Camperdown, Australia, 2050
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Dimitrovgrad, Bulgaria, 6400
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Pleven, Bulgaria, 5800
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1606
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Varna, Bulgaria, 9010
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Bad Lauterberg, Germany, 37431
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Berlin, Germany, 10115
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Görlitz, Germany, 02826
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Hannover, Germany, 30167
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Mainz, Germany, 55116
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Neuss, Germany, 41460
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Nürnberg, Germany, 90402
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Guatemala City, Guatemala, 01015
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Hong Kong, Hong Kong
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Riga, Latvia, 1002
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Kaunas, Lithuania, 51270
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Klaipeda, Lithuania, 92304
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Vilnius, Lithuania, 08661
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Guadalajara, Mexico, 44340
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Guadalajara, Mexico, 44650
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Mexico City, Mexico, 03100
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Mexico City, Mexico, 14080
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Mexico City, Mexico, 11650
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Mexico City, Mexico, 14610
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Monterrey, Mexico, 64460
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Pachuca, Mexico, 42086
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Brasov, Romania, 500365
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Bucharest, Romania
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Bucharest, Romania, 020475
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Bucharest, Romania, 050452
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Cluj-napoca, Romania, 400006
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Jud Covasna, Romania, 520064
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Mures, Romania, 540011
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Ploiesti, Romania, 100163
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Satu Mare, Romania, 3900
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Sibiu, Romania, 550245
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District of Columbia
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Washington, District of Columbia, United States, 20010
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Georgia
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Woodstock, Georgia, United States, 30189
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Illinois
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Chicago, Illinois, United States, 60607
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Springfield, Illinois, United States, 62704-1433
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New York
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Rochester, New York, United States, 14609
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Oregon
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Portland, Oregon, United States, 97239
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Texas
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Dallas, Texas, United States, 75246
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Midland, Texas, United States, 79707
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San Antonio, Texas, United States, 78229
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Virginia
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Richmond, Virginia, United States, 23249
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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 |
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Experimental: 1
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20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
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Experimental: 2
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20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
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Experimental: 3
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20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
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Experimental: 4
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20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
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Experimental: 5
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20mg sc weekly
10mg sc every 2 weeks
5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
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Placebo Comparator: 6
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sc weekly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Absolute change from baseline in HbAlc
Time Frame: Week 8
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Week 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Time Frame: Week 8
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Week 8
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Changes in lipid profile
Time Frame: Week 8
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Week 8
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AEs, laboratory parameters, primary pharmacokinetic parameters
Time Frame: Throughout study
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Throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC20688
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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