Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
- Status
- CompletedResults none
- Why it is watched
- population of special interest (non-obese / healthy / non-diabetic)
- Who it enrolls
- age 20 Years to 60 Years; no BMI minimum stated; non-obese participants included; conditions: Adult Subjects With Type1Diabetes and Insulin Microsecretion
- Interventions
- Dulaglutide; Placebo
- Conditions
- Adult Subjects With Type1Diabetes and Insulin Microsecretion
- Phase and size
- Phase 2 · 45 participants
- Dates
- Start 2019-01-31
Primary completion 2021-02-03 - Sponsor
- Hospices Civils de Lyon (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- HbA1c levelafter 24 weeks of treatment
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.