drugset / Trial / NCT03668470

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

NCT03668470

Phase 2 Completed 45 enrolled Hospices Civils de Lyon
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion associated with glucotoxicity. Previous trials have indicated that treatment with a Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function might improve glycemic control, reduce dose of insulin and risk of hypoglycemia. The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose After initial screening to select insulin microsecretors and a run-in period of one month, patients will be randomized into two arms and followed in parallel for 24 weeks : * Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual insulin regimen * Control group receiving placebo s.c weekly in addition to their usual insulin regimen. The primary endpoint is HbA1c value at 24 weeks

Timeline

Start
2019-01-31
Primary completion
2021-02-03
Completion
2021-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide 1.5 mg Subcutaneous