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NCT Number: NCT00909597

A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

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.

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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

Camperdown, New South Wales, Australia

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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 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.

Treatment and study plan

pioglitazone

Drug

30mg po once daily for 4 weeks, followed by 45mg once daily

taspoglutide

Drug

10mg sc once weekly

Primary outcomes

  1. Absolute change from baseline in HbA1c

    Time frame: 24 weeks

Secondary outcomes

  1. Proportion of patients achieving target HbA1c <=6.5%, <=7%

    Time frame: weeks 24, 52 and 104

  2. 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

  3. Adverse events; laboratory parameters; cardiovascular events

    Time frame: At each clinic visit up to 106 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 28, 2009
Registry last updated
Nov 2, 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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