A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00909597

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: taspoglutide Drug: pioglitazone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving target HbA1c <=6.5%, <=7% [ Time Frame: weeks 24, 52 and 104 ] [ Designated as safety issue: No ]
Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose [ Time Frame: weeks 24, 52 and 104 ] [ Designated as safety issue: No ]
Adverse events; laboratory parameters; cardiovascular events [ Time Frame: At each clinic visit up to 106 weeks ] [ Designated as safety issue: No ]

Enrollment:	756
Study Start Date:	May 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: taspoglutide 10mg sc once weekly
Experimental: 2	Drug: taspoglutide 10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Active Comparator: 3	Drug: pioglitazone 30mg po once daily for 4 weeks, followed by 45mg once daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909597

Show 147 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00909597 History of Changes
Other Study ID Numbers:	BC21893, 2009-009157-24
Study First Received:	May 27, 2009
Last Updated:	June 15, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012