Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

Conditions

• Adult Subjects With Type1Diabetes and Insulin Microsecretion

Eligibility Criteria

Sex

ALL

Age

20 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Dulaglutide — DRUG
  Dulaglutide 1.5mg : One injection per week during 24 weeks
• Placebo — DRUG
  Placebo: one injection per week during 24 weeks

Study Details

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

Key Dates

Start date

Jan 31, 2019

Status verified

Jul 2021

Primary completion

Feb 3, 2021

Completion

Feb 3, 2021

Study Design

Enrollment

45 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dulaglutide
  Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
• Placebo Comparator: placebo
  Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks

Primary Outcome Measure

HbA1c level [ Time Frame: after 24 weeks of treatment ]