E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with Type 1 Diabètes (T1D)> 4years |
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E.1.1.1 | Medical condition in easily understood language |
Adult patients with Type 1 Diabetes > 4years |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
E.1.2 | System Organ Class | 100000004860 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 >7.5 and <9.5%
- BMI<30.0kg/m2
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 24 weeks of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |