NCT03668470CompletedPhase 2
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial
Hospices Civils de Lyon7 sites in 1 country45 target enrollmentStarted: January 31, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 45
- Locations
- 7
- Primary Endpoint
- HbA1c level
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dulaglutide
Experimental
Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Intervention: Dulaglutide (Drug)
placebo
Placebo Comparator
Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
HbA1c level
Time Frame: after 24 weeks of treatment
Blood level
Secondary Outcomes
- Autoantibodies to GAD65(: before and after 24wks of treatment)
- Autoantibodies to IA-2(before and after 24wks of treatment)
- Daily insulin doses and basal/ prandial ratio(: before and after 24weeks of treatment)
- Glucagon levels fasting and following a MMT(before and after 24 weeks of treatment)
- AUC us C-peptide over AUC blood glucose levels following a MMT(before and after 24 weeks of treatment)
- : Body weight(before and after 24weeks of treatment)
- % carbohydrates(the run-in period (1 month) and after 24 weeks of treatment)
- AUC us C-peptide following a MMT(before and after 24 weeks of treatment)
- Daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range(the run-in period (1 month) and after 24 weeks of treatment)
- Number of symptomatic hypoglycemic episodes(20 months)
- Number of adverse events(20 months)
- insulin doses : basal/ prandial ratio(before and after 24weeks of treatment)
- Autoantibodies to ZnT8(before and after 24wks of treatment)
- coefficients of variation (CV)(the run-in period (1 month) and after 24 weeks of treatment)
Investigators
Study Sites (7)
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