E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 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 demonstrate the noninferiority of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL on glycemic control and variability in participants with diabetes mellitus |
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E.2.2 | Secondary objectives of the trial |
To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Gluclose Monitoring (CGM)
To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants with Type 1 Diabetes mellitus (T1DM)
Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year
HbA1c ≥ 7% (48 mmol/mol) and ≤ 10% (86 mmol/mol) at screening
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E.4 | Principal exclusion criteria |
Participants not on stable dose of basal insulin analog
Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening
Participants not using the same insulins (both basal and rapid) within 30 days prior to screening
Participants having received basal insulin dose ≥0.6 U/kg body weight within 30 days prior to screening
Participants having received any glucose lowering drugs (including any premixed insulins,human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening
End stage renal disease or on renal replacement treatment
Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery
Body weight change ≥5 kg within 3 months prior to screening
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E.5 End points |
E.5.1 | Primary end point(s) |
Time in glucose range - Percent (%) time in glucose range of ≥70 to ≤180 mg/dL (≥3.9 to ≤10 mmol/L) at Week 12, obtained using continuous glucose monitoring (CGM) |
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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) |
1) Glucose total coefficient of variation (CV) - Glucose total CV (%)
2) Glucose within-day CV - Glucose within-day CV (%)
3) Glucose between-day CV - Glucose between-day CV (%)
4) Glycated hemoglobin (HbA1c) - Change from baseline to week 12 in HbA1c
5) Fasting Plasma Glucose (FPG) - Change from baseline to week 12 in FPG
6) Time with Glucose < 70mg/dL - % time with glucose <70 mg/dL
7) Time with Glucose > 180 mg/dL - % time with glucose >180 mg/dL
8) Participants with hypoglycemic events - Number of participants with at least one hypoglycemic event
9) Hypoglycemic events per participant year - Number of hypoglycemic events per participant year
10) Participants with Adverse events - Number of participants with Adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Week 12
2) Week 12
3) Week 12
4) Baseline to Week 12
5) Baseline to Week 12
6) Week 12
7) Week 12
8) Baseline to Week 12
9) Baseline to Week 12
10) Baseline to Week 12 |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Germany |
Hungary |
Netherlands |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 8 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 8 |