Informations générales (source: ClinicalTrials.gov)
Interest of GLP1 Analogues (aGLP1) in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease (IBD) (DiagMICI)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
janvier 2022
décembre 2024
29 juin 2024
The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory
diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of
inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis.
Although the majority of IBD patients are not overweight, the prevalence of obesity in
this population remains significant, estimated at 15 to 40%. It has been shown that
obesity can impact the response to therapies used in IBD as well as the clinical course
of the disease:
1) plasma concentrations of immunomodulatory therapies are often lower in the obese
compared to those with a normal Body Mass Index (BMI) with a lower dose per kg of
the administered drug as well as an acceleration of drug clearance.
2nd) Surgical management of IBD is associated with a higher risk of peri- and
post-operative complications in obese patients, including an increase in operating time,
bleeding risk, length of hospital stay and percentage of post-operative infections.
3e) Finally, obesity seems to have a negative impact on the clinical course of IBD, with
a correlation between an increase in BMI and an increase in the number of
hospitalizations, the number of follow-up consultations and the need for therapeutic
escalation.
One of the common pathophysiological explanations between IBD and metabolic syndrome
(including type 2 diabetes and obesity), would involve metabolites in the gut that are
modulated by the gut microbiota.
Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of injectable antidiabetic
drugs that have revolutionized the management of type 2 diabetes. They include exenatide,
lixisenatide, liraglutide, dulaglutide and semaglutide. They combine an effect on
glycemic control but also usually a weight loss. In some countries, they are used in
non-diabetic obese patients, with a weight loss of up to -10 to -15%. These molecules
bind to GLP1 receptors, stimulate insulin secretion when blood glucose levels are high,
decrease glucagon secretion, slow gastric emptying and stimulate satiety. In addition to
glycemic control, weight reduction is most often associated.
In addition, some aGLP1s have been shown to reduce cardiovascular events in diabetics.
They are well tolerated, but their side effects are mainly digestive, such as nausea,
vomiting and sometimes diarrhea. These problems occur in about 20% of cases, most often
after the first injection, with vomiting requiring permanent cessation of treatment. Most
often they gradually subside, spontaneously or after symptomatic treatment, and allow
titration of the drug.
Due to the lack of studies and possible intestinal effects, aGLP1 is not recommended in
cases of severe gastrointestinal disease, and therefore in cases of IBD, although it is
not contraindicated.
The main objective of this study is to test the interest of these GLP1 analogues in type
2 diabetics with IBD, who are overweight and whose glycemic target is not reached. The
expected benefit is to facilitate diabetes control and weight loss in this population.
The second objective is to monitor the occurrence of adverse events in this population
with the different GLP1 analogues used.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Helene BEAUSSIER, PharmD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
- Patients between 18 and 75 years of age
- Patients with inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis
(UC))
- Patient with poorly controlled type 2 diabetes (defined as deviation from the set
glycemic target of more than 1% HbA1c)
- Patient with a BMI ≥ 25 kg/m2
- For women of childbearing age: effective contraception* during treatment and up to 5
weeks after discontinuation
* Any contraceptive method used regularly and appropriately that has a low failure
rate (i.e., less than 1% per year)
- Patient enrolled in a health insurance plan
- Francophone patient
- Patient with free, informed, written consent
Exclusion Criteria:
- Patient with a personal or family history of medullary thyroid cancer
- Patient with an active cancer
- Patient with a history of acute or chronic pancreatitis
- Patients with a history of hypersensitivity to GLP1 analogues (or to any other
component of the product)
- Patient with a history of severe GI intolerance to GLP-1 receptor agonists
- Patient already included in a risky interventional research protocol (RIPH1)
- Pregnant or breastfeeding women
- Patients with congestive heart failure New York Heart Association (NYHA) class IV
- Patient with end-stage renal disease
- Patients with clinically significant sustained elevation of resting heart rate
- Patient with anti-GAD antibodies in a previous workup at inclusion
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty
- Patients with inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis
(UC))
- Patient with poorly controlled type 2 diabetes (defined as deviation from the set
glycemic target of more than 1% HbA1c)
- Patient with a BMI ≥ 25 kg/m2
- For women of childbearing age: effective contraception* during treatment and up to 5
weeks after discontinuation
* Any contraceptive method used regularly and appropriately that has a low failure
rate (i.e., less than 1% per year)
- Patient enrolled in a health insurance plan
- Francophone patient
- Patient with free, informed, written consent
Exclusion Criteria:
- Patient with a personal or family history of medullary thyroid cancer
- Patient with an active cancer
- Patient with a history of acute or chronic pancreatitis
- Patients with a history of hypersensitivity to GLP1 analogues (or to any other
component of the product)
- Patient with a history of severe GI intolerance to GLP-1 receptor agonists
- Patient already included in a risky interventional research protocol (RIPH1)
- Pregnant or breastfeeding women
- Patients with congestive heart failure New York Heart Association (NYHA) class IV
- Patient with end-stage renal disease
- Patients with clinically significant sustained elevation of resting heart rate
- Patient with anti-GAD antibodies in a previous workup at inclusion
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty