Double DiabetesPhase 3TOLEDDONCT05305794
Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"
A Phase 3 study testing Insulin + semaglutide treatment, Usual insulin treatment and Biological check-up in people with Double Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Diabetes
- What is being tested?
- Insulin + semaglutide treatment, Usual insulin treatment and Biological check-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2022to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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 who have received GLP-1 agonist therapy or who received such therapy within the year prior to enrollment
- Patients who have received oral antidiabetic therapy within the month prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Benjamin BOUILLET, 03.80.29.34.53, benjamin.bouillet@chu-dijon.fr
About this study
Official title: Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study
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.
Read more
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).
- Conditions
- Double Diabetes
- Being tested
- Insulin + semaglutide treatment, Usual insulin treatment, Biological check-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Usual insulin treatmentDrug
Usual insulin treatment
Biological check-upBiological
at D0, D90 and D180
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: Insulin + semaglutide treatment; Biological: Biological check-up |
| Control | Active comparator | Not described Receives: Drug: Usual insulin treatment; Biological: Biological check-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent within glycemic target range (0.70-1.80 g/l)
Measured: Change from baseline at Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 Jul 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305794
- Sponsor's protocol ID
- BOUILLET PHRCI 2020
- Acronym
- TOLEDDO
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study
- ClinicalTrials.gov ID
- NCT05305794
- Acronym / sponsor ID
- TOLEDDO / BOUILLET PHRCI 2020
- Conditions
- Double Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Insulin + semaglutide treatment, Biological: Biological check-up |
| Control | Active comparator | Drug: Usual insulin treatment, Biological: Biological check-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin + semaglutide treatmentUsual 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) | Drug | Semaglutide |
| Usual insulin treatmentUsual insulin treatment | Drug | Control |
| Biological check-upat D0, D90 and D180 | Biological | Control, Semaglutide |
Primary outcome
Percentage of time spent within glycemic target range (0.70-1.80 g/l)
Time frame: Change from baseline at Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin + semaglutide treatment, Usual insulin treatment and Biological check-up in people with Double Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUILLET (03.80.29.34.53, benjamin.bouillet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent within glycemic target range (0.70-1.80 g/l) (time frame: Change from baseline at Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.