E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II 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 superiority of meal-time Faster-acting insulin aspart (FIAsp) in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of glycaemic control after 18-weeks of randomised treatment |
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E.2.2 | Secondary objectives of the trial |
• To compare meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of postprandial glucose (PPG) regulation after 18 weeks of randomised treatment
• To compare other efficacy and safety endpoints of meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, after 18 weeks of randomised treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥18 years at time the informed consent is signed by the Subject (Visit 1)
• Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to the screening visit (Visit 1)
• Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
• Current treatment with
a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
or
b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
• HbA1c by central laboratory
a) 7.5-9.5% (58 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1)
or
b) 7.5-9.0% (58 – 75 mmol/mol) (both inclusive) in the metformin + other OAD (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (Visit 1)
• Body mass index (BMI) ≤ 40.0 kg/m^2
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E.4 | Principal exclusion criteria |
• Any use of bolus insulin, except short-term use due to intermittent illness (no longer than14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
• Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) 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)
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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 18 weeks of randomised treatment |
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E.5.2 | Secondary end point(s) |
1. Self-measured plasma glucose (SMPG) 7- point profile
a. Post prandial plasma glucose (PPG), overall 2-hour mean (of breakfast, lunch, main evening meal)
b. Prandial plasma glucose (PG) increment, overall 2-hour mean (of breakfast, lunch, main evening meal)
2. Change from baseline in body weight
3. Number of treatment emergent hypoglycaemic episodes
4. Number of adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-2. After 18 weeks of randomised treatment
3.-4. During 18 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
Argentina |
India |
Mexico |
Romania |
Slovenia |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |