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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05305794
Recruitment Status : Active, not recruiting
First Posted : March 31, 2022
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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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).


Condition or disease Intervention/treatment Phase
Double Diabetes Drug: Insulin + semaglutide treatment Drug: Usual insulin treatment Biological: Biological check-up Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study
Actual Study Start Date : July 12, 2022
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide Drug: Insulin + semaglutide treatment
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)

Biological: Biological check-up
at D0, D90 and D180
Active Comparator: Control Drug: Usual insulin treatment
Usual insulin treatment

Biological: Biological check-up
at D0, D90 and D180


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of time spent within glycemic target range (0.70-1.80 g/l) [ Time Frame: Change from baseline at Day 180 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305794


Locations
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France
Chu Dijon Bourgogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT05305794    
Other Study ID Numbers: BOUILLET PHRCI 2020
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
 Insulin, Globin Zinc
Semaglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Glucagon-Like Peptide-1 Receptor Agonists