Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Genfit
Information provided by:
Genfit
ClinicalTrials.gov Identifier:
NCT01261494
First received: December 13, 2010
Last updated: July 12, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type II Diabetes Mellitus |
Drug: GFT505 80mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Genfit:
Primary Outcome Measures:
- HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Oral Glucose Tolerance Test (OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To evaluate the changes from baseline to end of treatment in OGTT parameters. Evaluation will be made prior the first treatment intake and 12 weeks after the first treatment intake.
- Fasting Plasma Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To evaluate the changes from baseline to end of treatment in fasting plasma Glucose. 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).
- Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To evaluate the changes from baseline to end of treatment in insulin resistance index. 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).
| Enrollment: | 97 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GFT505 80mg |
Drug: GFT505 80mg
hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
|
| Placebo Comparator: Matching placebo |
Drug: Placebo
hard gelatin capsules,oral administration,4 capsules per day before breakfast
|
Detailed Description:
The study period per patient is 16-20 weeks maximum and is conducted as follows :
- Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in);
- Treatment period: 12 weeks;
- Follow-up period: 2 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or post-menopausal female (defined as >12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
- Body Mass Index ≥27 and ≤45 kg/m².
- Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
- HbA1c ≥ 7.0% and <9.5%.
- Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.
Exclusion Criteria:
- Type I Diabetes Mellitus.
- Blood Pressure > 160 / 95 mmHg.
- Lipid-lowering drugs such as fibrates.
- Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
- Triglycerides (TG) > 400 mg/dL.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261494
Locations
| Bosnia and Herzegovina | |
| Site n°12 | |
| Banja Luka, Bosnia and Herzegovina, 78000 | |
| Site n°11 | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Latvia | |
| Site n°21 | |
| Riga, Latvia, LV 1004 | |
| Site n°22 | |
| Riga, Latvia, LV 1002 | |
| Site n°23 | |
| Valmiera, Latvia, LV4201 | |
| Macedonia, The Former Yugoslav Republic of | |
| Site n°33 | |
| Bitola, Macedonia, The Former Yugoslav Republic of, 7000 | |
| Site n°32 | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Site n°31 | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Moldova, Republic of | |
| Site n°41 | |
| Balti, Moldova, Republic of, 3112 | |
| Site n°42 | |
| Chisinau, Moldova, Republic of, 2025 | |
| Site n°43 | |
| Chisinau, Moldova, Republic of, 2068 | |
| Romania | |
| Site n°72 | |
| Oradea, Bihor County, Romania, 410167 | |
| Site n°66 | |
| Buzau, Buzau County, Romania, 120203 | |
| Site n°64 | |
| Cluj Napoca, Cluj County, Romania, 400006 | |
| Site n°65 | |
| Baia Mare, Maramures County, Romania, 430123 | |
| Site n°63 | |
| Targu Mures, Mures County, Romania, 540098 | |
| Site n°62 | |
| Targu Mures, Mures County, Romania, 540142 | |
| Site n°70 | |
| Ploiesti, Prahova County, Romania, 100342 | |
| Site n°71 | |
| Ploiesti, Prahova County, Romania, 100163 | |
| Site n°61 | |
| Sibiu, Sibiu County, Romania, 550245 | |
| Site n°67 | |
| Bucharest, Romania, 020045 | |
| Site n°69 | |
| Bucharest, Romania, 020045 | |
| Site n°68 | |
| Bucharest, Romania, 020475 | |
| Serbia | |
| Site n°56 | |
| Belgrade, Serbia, 11000 | |
| Site n°52 | |
| Belgrade, Serbia, 11000 | |
| Site n°53 | |
| Belgrade, Serbia, 11000 | |
| Site n°54 | |
| Kragujevac, Serbia, 34000 | |
| Site n°51 | |
| Nis, Serbia, 18000 | |
Sponsors and Collaborators
Genfit
Investigators
| Study Director: | Rémy HANF, Development Director | Genfit, France |
| Study Chair: | Bertrand CARIOU, Pr. | University Hospital of Nantes, France |
More Information
No publications provided
| Responsible Party: | Product Development Department, Genfit |
| ClinicalTrials.gov Identifier: | NCT01261494 History of Changes |
| Other Study ID Numbers: | GFT505-210-5, 2010-021986-60 |
| Study First Received: | December 13, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | Romania: Ethics Committee Romania: National Medicines Agency Latvia: Institutional Review Board Latvia: State Agency of Medicines Bosnia: Federal Ministry of Health Macedonia: Ethics Committee Macedonia: Ministry of Health Moldavia: Ministry of Health Serbia: Ethics Committee Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Keywords provided by Genfit:
|
Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Cardiovascular Diseases PPARs OGTT |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013