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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023219-32 | EudraCT Number |
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The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.
The study period per patient is 26 weeks: a selection period will precede a 8-week treatment period, a 6-week wash out period, a second 8-week treatment period in the second arm of treatment and a 2- week follow-up period.
Schedule:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFT505 80mg | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFT505 80mg | Drug | hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Infusion Rate (GIR) | To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Hepatic Glucose Production (HGP) in each patient | To evaluate in each patient the differences in Hepatic Glucose Production (HGP) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design. | 8 weeks |
| Changes in GIR (Glucose Infusion Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RĂ©my Hanf, Development Director | Genfit, France | Study Director |
| Bertrand CARIOU, Pr. | University Hospital of Nantes, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site n°1 | Nantes | 44093 | France | |||
| Site n°2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23715754 | Derived | Cariou B, Hanf R, Lambert-Porcheron S, Zair Y, Sauvinet V, Noel B, Flet L, Vidal H, Staels B, Laville M. Dual peroxisome proliferator-activated receptor alpha/delta agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects. Diabetes Care. 2013 Oct;36(10):2923-30. doi: 10.2337/dc12-2012. Epub 2013 May 28. | |
| 23703580 |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D056128 | Obesity, Abdominal |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C585906 | 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid |
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| Placebo | Drug | hard gelatin capsules, oral administration, 4 capsules per day before breakfast |
|
To compare the changes from baseline to endpoint in Glucose Infusion Rate (GIR). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period. |
| 8 weeks |
| Changes in HGP (Hepatic Glucose Production) | To compare the changes from baseline to endpoint in Hepatic Glucose Production (HGP). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period. | 8 weeks |
| Pierre-BĂ©nite |
| 69310 |
| France |
| Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29. |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006943 | Hyperglycemia |