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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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Washington D.C., District of Columbia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Rochester, New York, United States
Portland, Oregon, United States
Dallas, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Start Date
February 1, 2007
Primary Completion Date
November 1, 2007
Completion Date
November 1, 2007
Last Updated
November 2, 2016
306
ACTUAL participants
Placebo
DRUG
taspoglutide
DRUG
taspoglutide
DRUG
taspoglutide
DRUG
taspoglutide
DRUG
taspoglutide
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03821636