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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909597
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE May 28, 2009
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE May 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • Proportion of patients achieving target HbA1c <=6.5%, <=7% [ Time Frame: weeks 24, 52 and 104 ]
  • 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 ]
  • Adverse events; laboratory parameters; cardiovascular events [ Time Frame: At each clinic visit up to 106 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
  • Proportion of patients achieving target HbA1c <=6.5%, <=7% [ Time Frame: 24 weeks ]
  • 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: 24 weeks ]
  • Adverse events; laboratory parameters; cardiovascular events [ Time Frame: At each clinic visit up to 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • Drug: pioglitazone
    30mg po once daily for 4 weeks, followed by 45mg once daily
  • Drug: taspoglutide
    10mg sc once weekly
  • Drug: taspoglutide
    10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Study Arms  ICMJE
  • Active Comparator: pioglitazone
    Intervention: Drug: pioglitazone
  • Experimental: taspoglutide 10mg
    taspoglutide 10mg sc weekly
    Intervention: Drug: taspoglutide
  • Experimental: taspoglutide 10mg/20mg
    taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly
    Intervention: Drug: taspoglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2011)
756
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2009)
648
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Costa Rica,   France,   Germany,   Mexico,   New Zealand,   Peru,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00909597
Other Study ID Numbers  ICMJE BC21893
2009-009157-24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP