Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes" (TOLEDDO)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Enrolling

Phase 3

Conditions

Double Diabetes

Treatments

Biological: Biological check-up

Drug: Insulin + semaglutide treatment

Drug: Usual insulin treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05305794

BOUILLET PHRCI 2020

Details and patient eligibility

About

Between 16% and 22% of type 1 diabetic patients present a clinical and biological profile of insulin resistance favored by a family history of type 2 diabetes or metabolic syndrome. They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes.

For several years, GLP1 agonists have been successfully used in the treatment of type 2 diabetes, leading to very significant improvements in glycemic control and weight loss.

Because of the insulin-sensitizing power of GLP1 agonists, the investigators hypothesize that they could reduce insulin resistance in patients with "double diabetes" and thus improve their glycemic control.

The investigators propose to use in this study semaglutide, the most recent and most potent GLP1 agonist (superiority demonstrated compared to exenatide LP and dulaglutide) and administered as a weekly subcutaneous injection (in contrast to liraglutide administered daily).

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Person who has given written consent
Patient over 18 years of age
Patient with type 1 diabetes confirmed by a C-peptide below laboratory standards
Age at diagnosis < 35 years
Treated with optimized insulin therapy (multi-injections or pump) for at least 1 year, having received specific therapeutic education on insulin dose adaptation.
BMI (weight/height2) ≥ 27 Kg/m².
At least one of the following criteria:
- Family history of type 2 diabetes (parents, grandparents, uncles, aunts, brothers and sisters)
- Family history of obesity (BMI>30 Kg/m2) (parents, grandparents, uncles, aunts, siblings)
- Triglycerides > 1.50g/l (1.7mmol/l)
- HDL< 0.5 g/l (1.29 mmol/l) in women, HDL<0.4 g/l (1.03 mmol/l) in men
HbA1c ≥ 7.5% and < 12% in the 3 months preceding inclusion
Having continuous glucose monitoring by a CGM (Holter Glucose Monitoring) system: Guardian, Dexcom or Free Style Libre
For women of childbearing age: using an effective method of contraception until 2 months after the end of treatment. Effective contraception includes: hormonal contraception, intrauterine device, bilateral tubal occlusion, vasectomy and sexual abstinence

Exclusion criteria

person not affiliated to national health insurance
Pregnant, parturient or breastfeeding woman
HbA1c ≥12% in the 3 months preceding inclusion.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by a fundus examination performed in the 6 months preceding the selection
Person under a measure of legal protection (curatorship, guardianship)
Renal insufficiency (GFR<30 ml/mn)
Hepatic insufficiency (INR> 1.5)
BMI >40 kg/m².
History of bariatric surgery
History of pancreatitis
Allergy to the active substance or to one of the excipients of OZEMPIC®.
Patients treated with GLP1 agonists or oral antidiabetics in the month preceding month prior to inclusion