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

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: metformin Drug: pioglitazone Drug: placebo Drug: taspoglutide	Phase 3


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, 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 Type 2

Drug Information available for: Metformin Metformin hydrochloride 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:

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 ]


Enrollment:	326
Study Start Date:	October 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo in addition to 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.	Drug: metformin >1500 mg/day or maximum tolerated dose (MTD) Drug: pioglitazone >= 30 mg/day Drug: placebo sc once weekly Drug: taspoglutide 10 mg sc once weekly; Drug: taspoglutide 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Experimental: Taspoglutide 10mg Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment	Drug: metformin >1500 mg/day or maximum tolerated dose (MTD) Drug: pioglitazone >= 30 mg/day Drug: taspoglutide 10 mg sc once weekly;
Experimental: Taspoglutide 10mg/20mg Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.	Drug: metformin >1500 mg/day or maximum tolerated dose (MTD) Drug: pioglitazone >= 30 mg/day Drug: taspoglutide 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00744367 History of Changes
Other Study ID Numbers:	BC20963 2008-001744-39
Study First Received:	August 29, 2008
Last Updated:	August 3, 2016
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 Metformin	Glucagon-Like Peptide 1 Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 27, 2016