TOLEDDO

RecruitingPhase 3

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

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

Lead sponsor

Centre Hospitalier Universitaire Dijon

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 1 diabetes

Eligibility highlights

•BMI ≥27•HbA1c 7.5-12%

Primary endpoint

•CGM time-in-range

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05305794

Org study IDBOUILLET PHRCI 2020

Timeline

Milestones

Study first posted2022-03-31actual

Study start2022-07-12actual

Last update posted2025-12-18actual

Primary completion2028-08estimated (month precision)

Study completion2028-08estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 1 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

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

Time frame:Change from baseline at Day 180

CGM time-in-range

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.