Diabetes Mellitus, Type 2Phase 4REALISTNCT03648554
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
A Phase 4 study testing dulaglutide (TRULICITY®) 1.5 mg and reinforced dietary monitoring in people with Diabetes Mellitus, Type 2 and NASH - Nonalcoholic Steatohepatitis, run by Central Hospital, Nancy, France at 9 sites in France.
Trial summary
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- dulaglutide (TRULICITY®) 1.5 mg and reinforced dietary monitoring
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Sep 2019to 30 Mar 2024
- Phase
- Phase 4
- 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
- Age > 18 years, < 75 years
- Patients with moderately controlled type 2 diabetes under oral antidiabetic drugs (OADs) (i.e. biguanides, sulfonylureas, glinides, alpha-glucosidase inhibitors) at a stable dose since at least 3 months. Standard basal insulin treatments for at least 6 months before inclusion are allowed in addition to predefined authorized OADs.
- 7.0%≤HbA1c≤ 9.0% confirmed in two assays over the last six months
- 25 <BMI <40 kg/m2
- Patients carriers of confirmed stable non-alcoholic steatohepatitis diagnosed by liver biopsy dating less than six months, with a NAS score ≥ 4 with at least 1 point in each of the categories (steatosis, ballooning and lobular inflammation) and with a fibrosis score greater than stage 1 fibrosis but less than stage 4 fibrosis
- Stable weight during the six months prior to inclusion, i.e. the change in weight must not exceed 5% in the last six months since the last liver puncture biopsy (LPB).
Show all 10Show fewer
- Person volunteered to participate in the study, informed about study organization and having signed the consent form
- Person affiliated to or beneficiary of a social security plan
- Person undergone the medical examination adapted to research
- At randomization: The diagnosis and the stage of non-alcoholic steatohepatitis must be confirmed after centralized reading of the hepatic histology of the liver puncture biopsy (LPB) performed within six months prior to inclusion, by a pathologist designated for the study.
Who cannot join
- Patients who received a treatment with a GLP-1 agonist, SGLT2 inhibitors, Thiazolidinediones (TZDs), hepatoprotective drugs such as silymarine (Legalon®) or Ursodeoxycholic acid (Cholurso®, Delursan®, Ursolvan®), vitamin E or Betaine during the six months prior to inclusion (3 months before the reference biopsy). Any treatment with DPP-4 inhibitors should be stopped on inclusion.
- Patients receiving rapid or short-acting mealtime insulin or premixed insulin in the last 6 months before screening visit
- Type 1 Diabetes
- Patients with idiopathic hemochromatosis
- Patients carriers of hepatitis B or C
- Terminal renal impairment (calculated clearance < 15 ml/min according to the CKD-EPI formula)
Show all 25Show fewer
- Class III or IV congestive heart failure according to the NYHA classification
- Chronic alcoholism. The investigator while interviewing the patient at the baseline visit assesses alcohol consumption. This consumption must be limited to 30g/day of alcohol for men and 20g/day of alcohol for women
- Hepatic fibrosis with a Kleiner score ≥ F3 (for a score = F3, patients with a platelet count > 120,000 and an albumin concentration > 35 g/l can be included)
- Patients with gastrointestinal bleeding
- History of acute or chronic pancreatitis
- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma
- Patients who had bariatric surgery
- Patients who received drug treatment for obesity, notably Orlistat, during the last 6 months
- Patients with eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder) which may compromise the achievement of dietary reinforcement goals
- Patients with a known allergy or hypersensitivity to the study product or one of its excipients
- Any other condition deemed incompatible with the proper conduct of the study as determined by the investigator
- Patient having participated in another biomedical research with the taking of an experimental drug within 3 months prior to the screening visit or subject under an exclusion period for other biomedical research.
- Woman of childbearing age without effective contraception
- Person referred in articles L.1121-5, L.1121-7 and L.1121-8 of the Public Health Code:
- Pregnant, parturient or breastfeeding woman
- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)
- Adult person incapable of giving consent
- Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de CAEN
Caen, 14033
Michael JOUBERT
Michael JOUBERT
CHU de DIJON
Dijon, 21079
Jean-Michel PETIT
Jean-Michel PETIT
Chu Marseille
Marseille, 13915
Bénédicte GABORIT
Bénédicte GABORIT, PU PH
CHRU de MONTPELLIER
Montpellier, 34295
Stéphanie FAURE
Stéphanie FAURE
CHU de REIMS
Reims, 51092
Brigitte DELEMER
Brigitte DELEMER
CHU de ROUEN
Rouen, 76031
Gaëtan PREVOST
Gaëtan PREVOST
CHU de TOULOUSE
Toulouse, 31059
Hélène HANAIRE
Hélène HANAIRE
CHRU de NANCY
Vandœuvre-lès-Nancy, 54500
Siham BENZIRAR, +33 3 83 15 50 56, s.benzirar@chru-nancy.fr
Amandine SEIWERT, +33 3 83 15 35 63, A.SEIWERT@chru-nancy.fr
G.H.M les Portes du Sud
Vénissieux, 69200
Pierre SERUSCLAT
Pierre SERUSCLAT
About this study
Official title: A Multicentre Controlled and Randomized Study Assessing the Effect of Dulaglutide add-on to Dietary Reinforcement Versus Dietary Reinforcement Alone in Patients With Type 2 Diabetes and Carriers of a Non-alcoholic Steatohepatitis
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH.
Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group.
Read more
Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis.
Secondary objectives:
- After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life.
- At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.
Read the detailed description
This is a multicentre, open, prospective, randomized, controlled dietary reinforcement study.
- Treatment Group: dulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide in combinaison with reinforced dietary monitoring as same as control group.
- Control group: reinforced dietary monitoring with frequent dietary consultations, based on AHA recommendations:
All patients are monitored in the same way for dietary reinforcement.
The study will be conducted over the course of 80 weeks in 3 periods (13 visits):
- Period I: Run-in phase of 4 weeks
- Period II: Treatment phase of 52 weeks
- Period III: Follow-up phase of 24 weeks. The patient must return to the study centre to assess whether the response to treatment is time-dependent.
- Being tested
- dulaglutide (TRULICITY®) 1.5 mg, reinforced dietary monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dulaglutide (TRULICITY®) 1.5 mgDrug
dulaglutide (TRULICITY®) 1.5 mg subcutaneous administration, one weekly injection over 52 weeks of treatment
reinforced dietary monitoringOther
moderate caloric restriction individually adjusted according to the ideal weight and activity level, encouraging regular physical activity (about 30 minutes per day or 150-200 min per week)
| Study group | Role | What they receive |
|---|---|---|
| dulaglutide (TRULICITY®) 1.5 mg | Experimental | dulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide for 52 weeks in combinaison with reinforced dietary monitoring as same as control group. Receives: Drug: dulaglutide (TRULICITY®) 1.5 mg; Other: reinforced dietary monitoring |
| reinforced dietary monitoring | Sham comparator | reinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations Receives: Other: reinforced dietary monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone)
A responder is defined as having a histological improvement defined as the regression of non-alcoholic steatohepatitis (decrease of at least two points in the NASH Activity Score [NAS] measured on three components: steatosis, lobular inflammatory foci and hepatocyte ballooning) without worsening of fibrosis (defined by the stage of the Kleiner fibrosis classification) on liver histology obtained by liver puncture biopsy Score > 4 = NASH confirmed Score 3-4 = borderline Score < 3 = absence of NASH
Measured: after 52 weeks of treatment
Secondary outcomes (12)
Fibrosis Kleiner score
Mean Changes in Kleiner score of fibrosis with distribution of patients into 3 groups according to the evolution of the score: improvement, stability or worsening.
Measured: after 52 weeks of treatment
Fibrosis using Fibrotest score
Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha2-macroglobulin, haptoglobin)
Measured: after 52 weeks of treatment
Fibrosis marker parameter
Hyaluronic acid serum rate
Measured: after 52 weeks of treatment
Changes in serum levels of liver enzymes ALT and AST
ALT and AST levels
Measured: after 52 weeks of treatment
Changes in Lipid parameters
- LDL-cholesterol value
- HDL-cholesterol value
- Triglycerides value
Measured: after 52 weeks of treatment
Improvement in the glycemic control
Fasting glucose
Measured: after 52 weeks of treatment
overall glycemic control improvement
HbA1c
Measured: after 52 weeks of treatment
Change in body composition assessed by dual-energy x-ray absorptiometry scans
changes in fat mass
Measured: after 52 weeks of treatment
Change in quality of life
Quality of Life, Obesity and Diet Scale (QOLOD rating scale questionnaire).Items were grouped in 5 dimensions: physical impact, psycho-social impact, sexual impact, comfort with food, diet experience. Each item of the QOLOD questionnaire was graded from 1 to 5 (1: always/enormously; 2: often/a lot; 3: sometimes/moderately; 4: rarely/a little; 5: never/not at all). score was then calculated for each dimension by adding together its constituent items. Scores obtained by adding up answers graded from 1 to 5 of all items per dimension were transformed to convert the lowest and highest score possible to 0 and 100 respectively. Hence the higher the score, the better the quality of life.
Measured: after 52 weeks of treatment
Change in weight
variation in weight between the beginning and the end of treatment
Measured: after 52 weeks of treatment
ALT and AST levels
The sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates
Measured: At 24 weeks after completion of the treatment
Weight
The sustainability of dulaglutide (TRULICITY®) treatment on weight
Measured: At 24 weeks after completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Sep 2019 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open, prospective, randomized, controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Bruno GUERCI, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648554
- Sponsor's protocol ID
- 2018-002162-38
- Other IDs
- PSS2018/REALIST-GUERCI/AS, 2018
- Acronym
- REALIST
- Status last verified
- Jun 2019
- First submitted
- 27 Jul 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Controlled and Randomized Study Assessing the Effect of Dulaglutide add-on to Dietary Reinforcement Versus Dietary Reinforcement Alone in Patients With Type 2 Diabetes and Carriers of a Non-alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT03648554
- Acronym / sponsor ID
- REALIST / 2018-002162-38
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 27 Aug 2018 (actual)
- 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.
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH.
Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group.
Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis.
Secondary objectives:
- After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life.
- At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.
Detailed description
This is a multicentre, open, prospective, randomized, controlled dietary reinforcement study.
- Treatment Group: dulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide in combinaison with reinforced dietary monitoring as same as control group.
- Control group: reinforced dietary monitoring with frequent dietary consultations, based on AHA recommendations:
All patients are monitored in the same way for dietary reinforcement.
The study will be conducted over the course of 80 weeks in 3 periods (13 visits):
- Period I: Run-in phase of 4 weeks
- Period II: Treatment phase of 52 weeks
- Period III: Follow-up phase of 24 weeks. The patient must return to the study centre to assess whether the response to treatment is time-dependent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- open, prospective, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| dulaglutide (TRULICITY®) 1.5 mg | Experimental | Drug: dulaglutide (TRULICITY®) 1.5 mg, Other: reinforced dietary monitoringdulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide for 52 weeks in combinaison with reinforced dietary monitoring as same as control group. |
| reinforced dietary monitoring | Sham comparator | Other: reinforced dietary monitoringreinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years, < 75 years
- Patients with moderately controlled type 2 diabetes under oral antidiabetic drugs (OADs) (i.e. biguanides, sulfonylureas, glinides, alpha-glucosidase inhibitors) at a stable dose since at least 3 months. Standard basal insulin treatments for at least 6 months before inclusion are allowed in addition to predefined authorized OADs.
- 7.0%≤HbA1c≤ 9.0% confirmed in two assays over the last six months
- 25 <BMI <40 kg/m2
- Patients carriers of confirmed stable non-alcoholic steatohepatitis diagnosed by liver biopsy dating less than six months, with a NAS score ≥ 4 with at least 1 point in each of the categories (steatosis, ballooning and lobular inflammation) and with a fibrosis score greater than stage 1 fibrosis but less than stage 4 fibrosis
Key exclusion criteria (25 listed)
- Patients who received a treatment with a GLP-1 agonist, SGLT2 inhibitors, Thiazolidinediones (TZDs), hepatoprotective drugs such as silymarine (Legalon®) or Ursodeoxycholic acid (Cholurso®, Delursan®, Ursolvan®), vitamin E or Betaine during the six months prior to inclusion (3 months before the reference biopsy). Any treatment with DPP-4 inhibitors should be stopped on inclusion.
- Patients receiving rapid or short-acting mealtime insulin or premixed insulin in the last 6 months before screening visit
- Type 1 Diabetes
- Patients with idiopathic hemochromatosis
- Patients carriers of hepatitis B or C
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 |
|---|---|---|
| dulaglutide (TRULICITY®) 1.5 mgdulaglutide (TRULICITY®) 1.5 mg subcutaneous administration, one weekly injection over 52 weeks of treatment | Drug | dulaglutide (TRULICITY®) 1.5 mg |
| reinforced dietary monitoringmoderate caloric restriction individually adjusted according to the ideal weight and activity level, encouraging regular physical activity (about 30 minutes per day or 150-200 min per week) | Other | dulaglutide (TRULICITY®) 1.5 mg, reinforced dietary monitoring |
Primary outcome
Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone)
Time frame: after 52 weeks of treatment
A responder is defined as having a histological improvement defined as the regression of non-alcoholic steatohepatitis (decrease of at least two points in the NASH Activity Score [NAS] measured on three components: steatosis, lobular inflammatory foci and hepatocyte ballooning) without worsening of fibrosis (defined by the stage of the Kleiner fibrosis classification) on liver histology obtained by liver puncture biopsy Score > 4 = NASH confirmed Score 3-4 = borderline Score < 3 = absence of NASH
12 secondary outcomes
Fibrosis Kleiner score
Time frame: after 52 weeks of treatment
Fibrosis using Fibrotest score
Time frame: after 52 weeks of treatment
Fibrosis marker parameter
Time frame: after 52 weeks of treatment
Changes in serum levels of liver enzymes ALT and AST
Time frame: after 52 weeks of treatment
Changes in Lipid parameters
Time frame: after 52 weeks of treatment
Improvement in the glycemic control
Time frame: after 52 weeks of treatment
overall glycemic control improvement
Time frame: after 52 weeks of treatment
Change in body composition assessed by dual-energy x-ray absorptiometry scans
Time frame: after 52 weeks of treatment
Change in quality of life
Time frame: after 52 weeks of treatment
Change in weight
Time frame: after 52 weeks of treatment
ALT and AST levels
Time frame: At 24 weeks after completion of the treatment
Weight
Time frame: At 24 weeks after completion of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Bruno GUERCI principal investigator
CHRU de Nancy
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dulaglutide (TRULICITY®) 1.5 mg and reinforced dietary monitoring in people with Diabetes Mellitus, Type 2 and NASH - Nonalcoholic Steatohepatitis, run by Central Hospital, Nancy, France at 9 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 10 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno GUERCI, Professor (+ 33 3 83 15.50 33, b.guerci@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone) (time frame: after 52 weeks of treatment). 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 25 Jun 2019.