Insulin ResistancePhase 2NCT01271777
Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity
A Phase 2 study testing GFT505 80mg in people with Insulin Resistance and Abdominal Obesity, run by Genfit at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Insulin Resistance, 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
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2011to Nov 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference ≥94cm.
- Body Mass Index ≤ 45kg/m2.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) > 3.
Who cannot join
- Blood Pressure > 160 / 95 mmHg.
- Diabetes mellitus 1 or 2.
- Historical of bariatric surgery.
- Patient treated with a lipid-decreasing medication.
- A fasting plasma triglycerides concentration > 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration > 220mg/dL.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.
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.
Read the detailed description
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:
- Selection visit prior to treatment period (D-14 and D-1)
- D0 : randomisation visit
- Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)
- Wash out period for 6 weeks (D57 to D98)
- Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154)
- Follow up period for 2 weeks (D155 to D169)
- Conditions
- Insulin Resistance, Abdominal Obesity
- Being tested
- GFT505 80mg, Placebo
- Keywords
- Pre-diabetes, Clamp technique, PPARs, Insulin resistance
- Medical subject headings
- Insulin Resistance, Obesity, Abdominal, Glucose Intolerance
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 group | Role | What they receive |
|---|---|---|
| GFT505 80mg | Experimental | Not described Receives: Drug: GFT505 80mg |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
Changes in GIR (Glucose Infusion Rate)
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rémy Hanf, Development Director, Study director, Genfit, FranceBertrand CARIOU, Pr., Study chair, University Hospital of Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271777
- Sponsor's protocol ID
- GFT505-210-6
- Other IDs
- 2010-023219-32
- Status last verified
- Sep 2012
- First submitted
- 4 Jan 2011
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23715754Staels 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.
- ClinicalTrials.gov ID
- NCT01271777
- Acronym / sponsor ID
- GFT505-210-6
- Conditions
- Insulin Resistance, Abdominal Obesity
- Keywords
- Pre-diabetes, Clamp technique, PPARs, Insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Selection visit prior to treatment period (D-14 and D-1)
- D0 : randomisation visit
- Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)
- Wash out period for 6 weeks (D57 to D98)
- Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154)
- Follow up period for 2 weeks (D155 to D169)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFT505 80mg | Experimental | Drug: GFT505 80mg |
| Matching placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Waist circumference ≥94cm.
- Body Mass Index ≤ 45kg/m2.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) > 3.
Key exclusion criteria (5 listed)
- Blood Pressure > 160 / 95 mmHg.
- Diabetes mellitus 1 or 2.
- Historical of bariatric surgery.
- Patient treated with a lipid-decreasing medication.
- A fasting plasma triglycerides concentration > 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration > 220mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFT505 80mghard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast | Drug | GFT505 80mg |
| Placebohard gelatin capsules, oral administration, 4 capsules per day before breakfast | Drug | Matching placebo |
Primary outcome
Glucose Infusion Rate (GIR)
Time frame: 8 weeks
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.
3 secondary outcomes
Differences in Hepatic Glucose Production (HGP) in each patient
Time frame: 8 weeks
Changes in GIR (Glucose Infusion Rate)
Time frame: 8 weeks
Changes in HGP (Hepatic Glucose Production)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Derived from this study: PubMed 23715754Cariou 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.
- Derived from this study: PubMed 23703580Staels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémy Hanf, Development Director study director
Genfit, France
Bertrand CARIOU, Pr. study chair
University Hospital of Nantes, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFT505 80mg in people with Insulin Resistance and Abdominal Obesity, run by Genfit at 2 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 3 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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Glucose Infusion Rate (GIR) (time frame: 8 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 NCT01271777, 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 24 Sep 2012.