TOLEDDO: Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05305794

Collaborator

(none)

Enrollment

Location

Arms

24.7

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Double Diabetes	Drug: Insulin + semaglutide treatment Drug: Usual insulin treatment Biological: Biological check-up	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study

Actual Study Start Date :

Jul 12, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide	Drug: Insulin + semaglutide treatment Usual insulin treatment + semaglutide (0.25 mg/week for 4 weeks, then 0.50 mg/week for 4 weeks, then 1 mg/week for 18 weeks, i.e. a total duration of 26 weeks). Upon introduction of semaglutide (ozempic) treatment, insulin doses will be reduced by 10% (basal insulin, basal rate and bolus) Biological: Biological check-up at D0, D90 and D180
Active Comparator: Control	Drug: Usual insulin treatment Usual insulin treatment Biological: Biological check-up at D0, D90 and D180

Arm

Intervention/Treatment

Experimental: Semaglutide

Drug: Insulin + semaglutide treatment

Usual insulin treatment + semaglutide (0.25 mg/week for 4 weeks, then 0.50 mg/week for 4 weeks, then 1 mg/week for 18 weeks, i.e. a total duration of 26 weeks). Upon introduction of semaglutide (ozempic) treatment, insulin doses will be reduced by 10% (basal insulin, basal rate and bolus)

Biological: Biological check-up

at D0, D90 and D180

Active Comparator: Control

Drug: Usual insulin treatment

Usual insulin treatment

Biological: Biological check-up

at D0, D90 and D180

Outcome Measures

Primary Outcome Measures

Percentage of time spent within glycemic target range (0.70-1.80 g/l) [Change from baseline at Day 180]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Person who has given written consent
Patient over 18 years of age
Patient with type 1 diabetes confirmed by a negative C-peptide
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
Having continuous glucose monitoring by the Free Style Libre system
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%.
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®.
Patient receiving GLP1 agonist or oral antidiabetic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT05305794

Other Study ID Numbers:

BOUILLET PHRCI 2020

First Posted:

Mar 31, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Insulin

Insulin, Globin Zinc

Study Results

No Results Posted as of Jul 19, 2022