Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
Status:
Completed
Trial end date:
2021-02-03
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Hospices Civils de Lyon
Treatments:
Dulaglutide Immunoglobulin Fc Fragments Insulin Insulin, Globin Zinc