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Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes" (TOLEDDO)

Primary Purpose

Double Diabetes

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Insulin + semaglutide treatment
Usual insulin treatment
Biological check-up
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Double Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 9, 2022
Last Updated
June 12, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05305794
Brief Title
Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"
Acronym
TOLEDDO
Official Title
Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Double Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin + semaglutide treatment
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Usual insulin treatment
Intervention Description
Usual insulin treatment
Intervention Type
Biological
Intervention Name(s)
Biological check-up
Intervention Description
at D0, D90 and D180
Primary Outcome Measure Information:
Title
Percentage of time spent within glycemic target range (0.70-1.80 g/l)
Time Frame
Change from baseline at Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin BOUILLET
Phone
03.80.29.34.53
Email
benjamin.bouillet@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin BOUILLET
Phone
03.80.29.34.53
Email
benjamin.bouillet@chu-dijon.fr

12. IPD Sharing Statement

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Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

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