Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 27, 2009
Last updated: February 5, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: pioglitazone
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 (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

Resource links provided by NLM:

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:
  • Proportion of patients achieving target HbA1c <=6.5%, <=7% [ Time Frame: weeks 24, 52 and 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events; laboratory parameters; cardiovascular events [ Time Frame: At each clinic visit up to 106 weeks ] [ Designated as safety issue: No ]

Enrollment: 756
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc once weekly
Experimental: 2 Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Active Comparator: 3 Drug: pioglitazone
30mg po once daily for 4 weeks, followed by 45mg once daily


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT00909597

  Show 147 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00909597     History of Changes
Other Study ID Numbers: BC21893, 2009-009157-24
Study First Received: May 27, 2009
Last Updated: February 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 27, 2015