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Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GFT505 80mg
Placebo
Sponsored by
Genfit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site n°12
  • Site n°11
  • Site n°22
  • Site n°21
  • Site n°23
  • Site n°33
  • Site n°31
  • Site n°32
  • Site n°41
  • Site n°42
  • Site n°43
  • Site n°72
  • Site n°66
  • Site n°64
  • Site n°65
  • Site n°63
  • Site n°62
  • Site n°71
  • Site n°70
  • Site n°61
  • Site n°67
  • Site n°69
  • Site n°68
  • Site n°52
  • Site n°53
  • Site n°56
  • Site n°54
  • Site n°51

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GFT505 80mg

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

HbA1c
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)
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
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)]
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).

Full Information

First Posted
December 13, 2010
Last Updated
July 12, 2011
Sponsor
Genfit
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1. Study Identification

Unique Protocol Identification Number
NCT01261494
Brief Title
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genfit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GFT505 80mg
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GFT505 80mg
Intervention Description
hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
hard gelatin capsules,oral administration,4 capsules per day before breakfast
Primary Outcome Measure Information:
Title
HbA1c
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Oral Glucose Tolerance Test (OGTT)
Description
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.
Time Frame
12 weeks
Title
Fasting Plasma Glucose
Description
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).
Time Frame
12 weeks
Title
Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémy HANF, Development Director
Organizational Affiliation
Genfit, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr.
Organizational Affiliation
University Hospital of Nantes, France
Official's Role
Study Chair
Facility Information:
Facility Name
Site n°12
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Site n°11
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Site n°22
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Site n°21
City
Riga
ZIP/Postal Code
LV 1004
Country
Latvia
Facility Name
Site n°23
City
Valmiera
ZIP/Postal Code
LV4201
Country
Latvia
Facility Name
Site n°33
City
Bitola
ZIP/Postal Code
7000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Site n°31
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Site n°32
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Site n°41
City
Balti
ZIP/Postal Code
3112
Country
Moldova, Republic of
Facility Name
Site n°42
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Site n°43
City
Chisinau
ZIP/Postal Code
2068
Country
Moldova, Republic of
Facility Name
Site n°72
City
Oradea
State/Province
Bihor County
ZIP/Postal Code
410167
Country
Romania
Facility Name
Site n°66
City
Buzau
State/Province
Buzau County
ZIP/Postal Code
120203
Country
Romania
Facility Name
Site n°64
City
Cluj Napoca
State/Province
Cluj County
ZIP/Postal Code
400006
Country
Romania
Facility Name
Site n°65
City
Baia Mare
State/Province
Maramures County
ZIP/Postal Code
430123
Country
Romania
Facility Name
Site n°63
City
Targu Mures
State/Province
Mures County
ZIP/Postal Code
540098
Country
Romania
Facility Name
Site n°62
City
Targu Mures
State/Province
Mures County
ZIP/Postal Code
540142
Country
Romania
Facility Name
Site n°71
City
Ploiesti
State/Province
Prahova County
ZIP/Postal Code
100163
Country
Romania
Facility Name
Site n°70
City
Ploiesti
State/Province
Prahova County
ZIP/Postal Code
100342
Country
Romania
Facility Name
Site n°61
City
Sibiu
State/Province
Sibiu County
ZIP/Postal Code
550245
Country
Romania
Facility Name
Site n°67
City
Bucharest
ZIP/Postal Code
020045
Country
Romania
Facility Name
Site n°69
City
Bucharest
ZIP/Postal Code
020045
Country
Romania
Facility Name
Site n°68
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Site n°52
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Site n°53
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Site n°56
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Site n°54
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Site n°51
City
Nis
ZIP/Postal Code
18000
Country
Serbia

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Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

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