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A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

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A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

NCT00909597•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•adult patients, 18-75 years of age;
•type 2 diabetes mellitus;
•treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening;
•HbA1c \>=7.0% and \<=10% at screening;
•stable weight +/-5% for \>=12 weeks prior to screening.

Exclusion Criteria

•type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
•clinically significant diabetic complications;
•clinically symptomatic gastrointestinal disease;
•\>3 episodes of severe hypoglycemia within 6 months before screening.

Locations (147)

Buena Park, California, United States

Chino, California, United States

Los Angeles, California, United States

Rancho Cucamonga, California, United States

Roseville, California, United States

Santa Ana, California, United States

Chiefland, Florida, United States

Coral Gables, Florida, United States

Daytona Beach, Florida, United States

Panama City, Florida, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

November 2, 2016

Enrollment

756

ACTUAL participants

Conditions

Diabetes Mellitus Type 2

Interventions

pioglitazone

DRUG

taspoglutide

DRUG

taspoglutide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

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.

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A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

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