E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 1 |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 confirm efficacy of treatment with meal time faster-acting insulin aspart (FIAsp) in terms of glycaemic control measured by change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of randomised treatment by comparing it to meal time insulin aspart both in combination with insulin detemir, using a non-inferiority approach. |
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E.2.2 | Secondary objectives of the trial |
Confirm
a) superiority of meal time FIAsp compared to meal time insulin aspart both in combination with insulin detemir after 26 weeks of randomised treatment in terms of:
• Post prandial glucose regulation
• Number of hypoglycaemic episodes
• Body weight regulation
b) efficacy of treatm. with post meal FIAsp in terms of glycaemic control measured by change from baseline in HbA1c after 26 weeks of randomised treatm. by comparing it to meal time insulin aspart both in combination with insulin detemir, using a non-inferiority approach.
c) superiority of post meal FIAsp compared to meal time insulin aspart both in combination with insulin detemir after 26 weeks of randomised treatm. in terms of:
• No. of hypoglycaemic episodes
• Body weight regulation
Objectives for the 26 weeks additional treatm. period:
To compare safety and efficacy of treatm. with meal time FIAsp and meal time insulin aspart, both in combination with insulin detemir, after 52 weeks of randomised treatm. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The Sub study will take place in Germany and Poland:
Title : CGM&Frequently sampled Meal test sub study
Date and version : Addendum version 4.0 25jun2013
Objectives: To compare efficacy and safety of treatment with meal time FIAsp versus meal time insulin aspart, and post meal FIAsp versus meal time insulin aspart, both in combination with insulin detemir with regard to postprandial and overall glucose regulation during the 10 to 14 days of CGM. |
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E.3 | Principal inclusion criteria |
• Female or male, age 18 years or older at the time of screening (Visit 1)
• Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1)
• Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1)
• Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1)
• HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
• Body Mass Index (BMI) equal to or below 35.0 kg/m^2
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E.4 | Principal exclusion criteria |
• Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1)
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)
• Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 26 weeks of randomised treatment |
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E.5.2 | Secondary end point(s) |
Confirmatory secondary endpoints:
1. Change from baseline in 2-hour PPG increment (meal test)
2. Change from baseline in HbA1c (post meal arm)
3. Number of treatment emergent confirmed hypoglycaemic episodes
4. Change from baseline in body weight
Key secondary endpoints for the 26 weeks additional treatment period:
5. Adverse events
6. HbA1c
7. PPG |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After 26 weeks of randomised treatment
2. After 26 weeks of randomised treatment
3. From baseline until week 26
4. After 26 weeks of randomised treatment
5. After 52 weeks of randomised treatment
6. After 52 weeks of randomised treatment
7. After 52 weeks of randomised 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 | No |
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) | Yes |
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 | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 3 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 |
European Union |
Canada |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 23 |