Dulaglutide And Insulin MicrosecretiON in type I Diabetes - DIAMOND

Phase 1

• Conditions: Adult patients with Type 1 Diabètes (T1D)> 4years; MedDRA version: 20.0Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 100000004860; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-000393-29-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Adult patients with T1D> 4years, with age range 20-60years
- Diabetes onset after the age of 15years
- Duration of diabetes <15 years
- Treated with continuous sub-cutaneous insulin infusions (CSI) or multiple daily injections of insulin (MDI)
- Measuring their blood sugar at least four times daily
- Glycated hemoglobin (HbA1C) at screening >7.5 and <9.5%
- BMI<30.0kg/m2
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with type 2 diabetes (T2D)
-Subjects with history of severe hypoglycemia or recent history of diabetic ketoacidosis
-History of gastrointestinal disease with prolonged nausea or vomiting, liver or kidney diseases, pancreatitis, thyroid medullary cancer or familial history of multiple endocrine neoplasia type 2
-Estimated glomerular filtration rate<60ml/min/ 1.73m2 (CKD-EPI method)
-Any uncontrolled disease
-Chronic use of drugs that directly affect GI mobility
-Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified