Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01261494 |
Recruitment Status
:
Completed
First Posted
: December 16, 2010
Last Update Posted
: July 13, 2011
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Sponsor:
Genfit
Information provided by:
Genfit
Tracking Information | |||||||
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First Submitted Date ICMJE | December 13, 2010 | ||||||
First Posted Date ICMJE | December 16, 2010 | ||||||
Last Update Posted Date | July 13, 2011 | ||||||
Study Start Date ICMJE | December 2010 | ||||||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
HbA1c [ Time Frame: 12 weeks ] To evaluate after 12 weeks of oral administration of double blind treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo. Evaluation will be made during the selection period, prior any drug intake, and 4, 8, 12 weeks after the first treatment intake as well as 2 weeks after the last treatment intake (follow up period).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01261494 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus | ||||||
Official Title ICMJE | A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 12 Weeks in Patients With Type 2 Diabetes Mellitus. A Multicentre, Randomised, Double Blind, Placebo-Controlled Study. | ||||||
Brief Summary | This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose. And to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 for 12 weeks in patients with type 2 diabetes mellitus. |
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Detailed Description | The study period per patient is 16-20 weeks maximum and is conducted as follows :
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Type II Diabetes Mellitus | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
97 | ||||||
Original Estimated Enrollment ICMJE |
120 | ||||||
Actual Study Completion Date | June 2011 | ||||||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Bosnia and Herzegovina, Latvia, Macedonia, The Former Yugoslav Republic of, Moldova, Republic of, Romania, Serbia | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01261494 | ||||||
Other Study ID Numbers ICMJE | GFT505-210-5 2010-021986-60 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Product Development Department, Genfit | ||||||
Study Sponsor ICMJE | Genfit | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Genfit | ||||||
Verification Date | July 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |