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Impaired Glucose TolerancePhase 2NCT01275469

Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.

A Phase 2 study testing GFT505 80mg in people with Impaired Glucose Tolerance and Abdominal Obesity, run by Genfit at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Impaired Glucose Tolerance, Abdominal Obesity
What is being tested?
GFT505 80mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
20 sitesFrance
Study dates
Jun 2009to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or post-menopausal female.
  • Waist circumference ≥94cm for male, ≥ 80cm for female.
  • Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.
  • 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).

Who cannot join

  • Body Mass Index (BMI) ≥ 40 kg/m².
  • Blood Pressure > 160 / 95 mmHg.
  • Known Type I or type II Diabetes Mellitus.
  • Glycated haemoglobin (HbA1c) >7%.
  • A fasting TG > 400mg/dl and a LDL-C > 220mg/dl.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Site n°31

    Angers, 49000

  • Site n°32

    Angers, 49000

  • Site n°36

    Angers, 49000

  • Site n°37

    Angers, 49000

  • Site n°34

    Angers, 49100

  • Site n°35

    Angers, 49100

  • Site n°39

    Angers, 49100

  • Site n°17

    Briollay, 49125

  • Site n°16

    Cholet, 49300

  • Site n°19

    Cholet, 49300

  • Site n°14

    Le Mesnil-en-Vallée, 49410

  • Site n°10

    Mûrs-Erigné, 49610

  • Site n°12

    Mûrs-Erigné, 49610

  • Site n°2

    Nantes, 44093

  • Site n°13

    Parçay-les-Pins, 49390

  • Site n°1

    Paris, 75013

  • Site n°15

    Segré, 49500

  • Site n°11

    Thouars, 79100

  • Site n°30

    Tiercé, 49125

  • Site n°18

    Vihiers, 49310

Other trials in France

About this study

Official title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.

Read the detailed description

The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.

Being tested
GFT505 80mg, Placebo
Keywords
Impaired Glucose tolerance, OGTT, PPARs
Medical subject headings
Glucose Intolerance, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GFT505 80mgDrug

    Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.

  • PlaceboDrug

    Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Study groups in NCT01275469
Study groupRoleWhat they receive
GFT505 80mgExperimentalNot described
Receives: Drug: GFT505 80mg
Matching placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral Glucose test Tolerance (OGTT)

    To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.

    Measured: 4 weeks

Secondary outcomes (5)

  1. Volume oxygen maximal (VO2max)

    To evaluate the efficacy of GFT505 80mg compared with placebo in improving the VO2max at physical exercise test. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.

    Measured: 5 weeks

  2. Respiratory parameters measured during the physical exercise test

    To describe the changes on others parameters measured during the physical exercise test : Volume carbon dioxide (VCO2), Respiratory quotient (RQ), Lactate concentration. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.

    Measured: 5 weeks

  3. Fasting Glycemia and Insulinemia

    To describe the changes of fasting glycaemia and insulinemia in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.

    Measured: 5 weeks

  4. HOMA index (Homeostasis Model Assessment)

    To describe the changes of HOMA index in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.

    Measured: 5 weeks

  5. Lipids

    To describe the changes in Triglycerides (TG), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C) and non High Density Lipoprotein Cholesterol (non-HDL-C) levels in the two groups. Evaluation will be made the first day prior any drug intake, then 2-3, and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit).

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2011 (estimated)
  2. Study startJun 2009
  3. Primary completionDec 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01275469
Sponsor's protocol ID
GFT505-209-4
Other IDs
2009-011003-23, 2009
Status last verified
Jan 2011
First submitted
10 Jan 2011
Last updated
12 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23703580

  • Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.

    PubMed 21816979

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GFT505 80mg in people with Impaired Glucose Tolerance and Abdominal Obesity, run by Genfit at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral Glucose test Tolerance (OGTT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01275469, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.

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