TOLEDDO: Effect of weekly GLP1 agonist treatment in "double diabetes": a randomized, open-label study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Oct 2024 → ongoing

Decision date (initial)

2024-07-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514906-30-00

EudraCT number

2021-003880-88

ClinicalTrials.gov

NCT05305794

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide on the change in the percentage of time spent within the glycemic target (0.70-1.80 g/l) between 0 and 6 months compared with standard treatment.

Secondary objectives 12

1. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on HbA1c
2. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on weight, waist circumference
3. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on daily dose of insulin administered
4. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on glycemic variability
5. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on the occurrence of hypoglycemia
6. To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide compared with standard treatment on the possible occurrence of undesirable effects
7. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on percentage of time spent within glycemic target range (0.70-1.80 g/l)
8. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on HbA1c
9. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on weight, waist circumference
10. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on daily dose of insulin administered
11. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on glycemic variability
12. Study the effect of semaglutide treatment between D0 and D90, as well as between D90 and D180 on the occurrence of hypoglycemia

Conditions and MedDRA coding

"double diabetes"

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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

Exclusion criteria 13

1. Person not affiliated to a national health insurance
2. Pregnant, parturient or nursing woman
3. HbA1c ≥ 12% in the 3 months prior to inclusion
4. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by fundus examination performed within 6 months prior to selection
5. Person subject to a measure of legal protection (guardianship, tutorship)
6. Person subject to a measure of court protection
7. Renal impairment (GFR < 30 ml/mn)
8. Hepatic impairment (INR > 1.5)
9. BMI > 40 kg/m²
10. History of bariatric surgery
11. History of pancreatitis
12. Allergy to the active substance or to one of the excipients of OZEMPIC®
13. Patients treated with GLP1 agonists or oral antidiabetics in the month prior to inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.

Secondary endpoints 6

1. HbA1c
2. Weight, waist circumference
3. Daily dose of insulin administered
4. Glycemic variability, assessed on data from continuous glucose recording using a continuous glucose meter (Free Style Libre, Guardian or Dexcom) by Standard Deviation (SD) and Mean Amplitude of Glycemic Excursions (MAGE). We will look at the variation in each criterion between the 2 groups between t0 and t6 months, between t0 and 3 months and between t3 months and t6 months.
5. interstitial glucose time < 0.7 g/l and <0.54 g/l (Free Style Libre data)
6. Percentage of adverse events in the 2 groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets recherche

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets recherche

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications