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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2	Drug: metformin; Drug: pioglitazone; Drug: placebo; Drug: taspoglutide	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	326 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	October 2008
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. 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 ]
2. Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout the study ]

Eligibility Criteria

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

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  Show 113 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00744367 History of Changes
Other Study ID Numbers:	BC20963; 2008-001744-39
First Posted:	September 1, 2008
Last Update Posted:	August 5, 2016
Last Verified:	August 2016

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