NCT05305794

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
27mo left

Started Jul 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jul 2022Aug 2028

First Submitted

Initial submission to the registry

March 9, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

6.1 years

First QC Date

March 9, 2022

Last Update Submit

December 11, 2025

Conditions

Double Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of time spent within glycemic target range (0.70-1.80 g/l)

    Change from baseline at Day 180

Study Arms (2)

Semaglutide

EXPERIMENTAL
Drug: Insulin + semaglutide treatmentBiological: Biological check-up

Control

ACTIVE COMPARATOR
Drug: Usual insulin treatmentBiological: Biological check-up

Interventions

Insulin + semaglutide treatmentDRUG

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)

Semaglutide
Usual insulin treatmentDRUG

Usual insulin treatment

Control
Biological check-upBIOLOGICAL

at D0, D90 and D180

ControlSemaglutide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • person not affiliated to national health insurance
  • Pregnant, parturient or breastfeeding woman
  • 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®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Benjamin BOUILLET

CONTACT

03.80.29.34.53benjamin.bouillet@chu-dijon.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 31, 2022

Study Start

July 12, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

FR(1)