Adult patients with Type 1 Diabètes (T1D)> 4years MedDRA version: 20.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860 MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: TRULICITY
Pharmaceutical Form: Solution for injection
Other descriptive name: DULAGLUTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceu
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with T1D> 4years, with age range 20-60years - Diabetes onset after the age of 15years - Duration of diabetes 7.5 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with type 2 diabetes (T2D) - Subjects with history of severe hypoglycemia or recent history of diabetic ketoacidosis - History of gastrointestinal disease with prolonged 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) - Any uncontrolled disease - Chronic use of drugs that directly affect GI mobility - Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if patients with T1D and insulin microsecretion with 1.5mg Dulaglutide once weekly (QW) as add-on therapy to insulin, will have a significantly different HbA1C level at 24 weeks compared to the HbA1c level in placebo-treated T1D patients;Secondary Objective: to evaluate impact of Dulaglutide vs placebo - on the area under curve (AUC) of ultra-sensitive (us) C-peptide response following an oral mixed meal test (MMT) before and after 24 weeks of treatment - on fasting and AUC glucagon levels after a MMT, before and after 24 weeks of treatment - on the ratio of the AUC of us C-peptide over the AUC of glucose levels following a MMT, before and after 24 weeks of treatment - on the changes in the daily percent time spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, and CGM data analysis to assess blood glucose variability, during the run-in period and after 24 weeks. - on the daily insulin doses and basal/ prandial ratio before and after 24 weeks of treatment - on the body weight before and after 24 weeks of treatment - on the mean carbohydrate intake during the run-in period and after 24 weeks - on the number of symptomatic (both minor and severe) hypoglycemic episodes during the study ;Primary end point(s): HbA1C levels at 24 weeks;Timepoint(s) of evaluation of this end point: 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -AUC us C-peptide following a MMT -Glucagon levels fasting and following a MMT -AUC us C-peptide over AUC blood glucose levels following a MMT -Daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range, coefficients of variation (CV) and standard deviation values (SD) as well as the average daily risk change (ADRR) of glucose values. -Daily insulin doses and basal/ prandial ratio -Body weight -Meal composition and % carbohydrates ;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment | — |
Countries
France
Contacts
Public ContactSylvie GALVAIN
Hospices Civils de lyon
Outcome results
None listed