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OpenTrials
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NCT Number: NCT00744367

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brasília, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

>1500 mg/day or maximum tolerated dose (MTD)

pioglitazone

Drug

>= 30 mg/day

Placebo

Drug

sc once weekly

taspoglutide

Drug

10 mg sc once weekly;

Primary outcomes

  1. Absolute change from baseline in HbA1c

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2008
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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