Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-02-03

Brief Summary

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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

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Detailed Description

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Conditions

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Adult Subjects With Type1Diabetes and Insulin Microsecretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentric, investigator-initiated, randomized, double-blinded, therapeutic clinical trial, placebo-controlled, two arm parallel group intervention trial during 24 weeks, phase II.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dulaglutide

Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks

Group Type EXPERIMENTAL

Dulaglutide

Intervention Type DRUG

Dulaglutide 1.5mg : One injection per week during 24 weeks

placebo

Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: one injection per week during 24 weeks

Interventions

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Dulaglutide

Dulaglutide 1.5mg : One injection per week during 24 weeks

Intervention Type DRUG

Placebo

Placebo: one injection per week during 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No