A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00744367

Purpose

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin 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:

Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2010

Arms	Assigned Interventions
1: Experimental	Drug: taspoglutide 10 mg sc once weekly; Drug: pioglitazone >= 30 mg/day Drug: metformin >1500 mg/day or MTD
2: Experimental	Drug: taspoglutide 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly) Drug: pioglitazone >= 30 mg/day Drug: metformin >1500 mg/day or MTD
3: Placebo Comparator	Drug: placebo sc once weekly Drug: pioglitazone >= 30 mg/day Drug: metformin >1500 mg/day or MTD

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 age;
type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
HbA1c >=7.0% and <=10.0% at screening;
BMI >= 25 (>23 for Asians) and <=45 kg/m2 at screening;
stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
evidence of clinically significant diabetic complications;
clinically symptomatic gastrointestinal disease;
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
known hemoglobinopathy or chronic anemia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744367

Contacts

Contact: Please reference Study ID Number: BC20963	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 113 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BC20963, 2008-001744-39
Study First Received:	August 29, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00744367 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Physiological Effects of Drugs
Metformin

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009