Type II Diabetes MellitusPhase 2NCT01261494
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing GFT505 80mg in people with Type II Diabetes Mellitus, run by Genfit at 28 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type II Diabetes Mellitus
- 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
- 97 participants
- Where
- 28 sitesin 6 countries
- Study dates
- Dec 2010to Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Romania12 sites
Site n°65
Baia Mare, Maramureş, 430123
Site n°67
Bucharest, 020045
Site n°69
Bucharest, 020045
Site n°68
Bucharest, 020475
Site n°66
Buzău, Buzău, 120203
Site n°64
Cluj-Napoca, Cluj, 400006
Site n°72
Oradea, Bihor County, 410167
Site n°71
Ploieşti, Prahova, 100163
Site n°70
Ploieşti, Prahova, 100342
Site n°61
Sibiu, Sibiu County, 550245
Site n°63
Târgu Mureş, Mureș County, 540098
Site n°62
Târgu Mureş, Mureș County, 540142
Serbia5 sites
Site n°52
Belgrade, 11000
Site n°53
Belgrade, 11000
Site n°56
Belgrade, 11000
Site n°54
Kragujevac, 34000
Site n°51
Niš, 18000
Latvia3 sites
Site n°22
Riga, LV 1002
Site n°21
Riga, LV 1004
Site n°23
Valmiera, LV4201
Moldova3 sites
Site n°41
Bălţi, 3112
Site n°42
Chisinau, 2025
Site n°43
Chisinau, 2068
North Macedonia3 sites
Site n°33
Bitola, 7000
Site n°31
Skopje, 1000
Site n°32
Skopje, 1000
Bosnia and Herzegovina2 sites
Site n°12
Banja Luka, 78000
Site n°11
Sarajevo, 71000
About this study
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.
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.
Read the 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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- GFT505 80mg, Placebo
- Keywords
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases
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.
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).
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT01261494
- Sponsor's protocol ID
- GFT505-210-5
- Other IDs
- 2010-021986-60
- Status last verified
- Jul 2011
- First submitted
- 13 Dec 2010
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01261494
- Acronym / sponsor ID
- GFT505-210-5
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Cardiovascular Diseases, PPARs, OGTT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Dec 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
HbA1c
Time frame: 12 weeks
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).
3 secondary outcomes
Oral Glucose Tolerance Test (OGTT)
Time frame: 12 weeks
Fasting Plasma Glucose
Time frame: 12 weeks
Insulin resistance Index [fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR)]
Time frame: 12 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 13 Jul 2011.
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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
28 sites in 6 countries: 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 Type II Diabetes Mellitus, run by Genfit at 28 sites in 6 countries.
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 5 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 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Romania, Serbia, Latvia, Moldova, North Macedonia and 1 more country. 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?
HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.