Status:
COMPLETED
A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00460941
Start Date
April 1 2007
End Date
January 1 2008
Last Update
November 2 2016
Active Locations (29)
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1
Harrisburg, Arkansas, United States, 72432
2
Hot Springs, Arkansas, United States, 71913
3
Jonesboro, Arkansas, United States, 72401
4
National City, California, United States, 91950