Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes (DIAMOND GLP1)

Civil Hospices of Lyon

Status and phase

Completed

Phase 2

Conditions

Adult Subjects With Type1Diabetes and Insulin Microsecretion

Treatments

Drug: Dulaglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03668470

69HCL18_0047

Details and patient eligibility

About

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

Enrollment

45 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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 and <10%
16.0 kg/m2 <BMI<30.0kg/m2
Patients with childbearing potential should use effective contraception, defined as methods with a failure rate ≤ 2 % per year (OMS 2011) during the study.
Patients who gave its written informed consent to participate to the study
Patients affiliated to a social insurance regime

Randomization criteria:

Patients with fasting ultra-sensitive (us) C-peptide above 15pmol/l

Exclusion criteria

Patients are not eligible for this study if any of the following exclusion criteria apply:
Patients with type 2 diabetes (T2D)
Hypersensitivity to dulaglutide and/or any of its excipients
Subjects with history of severe hypoglycemia or recent (< 6 months) history of diabetic ketoacidosis
History of gastrointestinal disease with prolonged (> 3 months) 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)
Congestive heart failure
Any uncontrolled disease, cancers essentially
Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings
Use of tricyclic antidepressant, selective serotonin reuptake inhibitor, triptans, neuroleptic drugs and glucocorticoid.
Patient who participated in another clinical trial on experimental drug in the previous 30 days
Patients of childbearing potential who are not using adequate contraception; Female patients who are pregnant or lactating.
Gastric bypass surgery
Patients under guardianship