E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects with type 2 diabetes currently treated with insulin qualifying for intensified treatment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053247 |
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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 |
The primary objective is to investigate the long-term safety and tolerability of SIBA in combination with insulin aspart. This is done by comparing SIBA + insulin aspart � OAD(s) to insulin glargine + insulin aspart � OAD(s) after 78 weeks of treatment (52 weeks of treatment in NN1250-3582 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: adverse events hypoglycaemic episodes clinical evaluation central laboratory assessments body weight insulin dose |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the efficacy between SIBA and insulin glargine, both in combination with insulin aspart � OAD(s), after 78 weeks of treatment, in terms of the listed efficacy assessments from which endpoints will be calculated: HbA1c (central laboratory) fasting plasma glucose (FPG) measured at a central laboratory 9-point self-measured plasma glucose (SMPG) profile 4-point self-measured plasma glucose (SMPG) profile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent obtained before any extension trial-related activities. (Extension trial related activities are defined as any procedure that would not have been performed during normal management of the subject or as part of trial NN1250-3582). 2. The subject must have completed the 52-week treatment period (Visit 41 in trial NN1250-3582). |
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E.4 | Principal exclusion criteria |
1. Previous participation in this trial. Participation is defined as participation in any Visit 43 related procedures. 2. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. 3. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors. 4. For pioglitazone user: clinically significant peripheral oedema or contraindications/restrictions to pioglitazone use. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events − number of events by medical event of special interest (MESI), system organ class and preferred term, seriousness, severity, relation to trial drug and device, and withdrawal due to AE s and outcome. Hypoglycaemic episodes − number of episodes by severity (classified according to the ADA (American Diabetes Association) definition and the additional definition for minor episodes) − number of nocturnal episodes by severity (classified according to the ADA definition and the additional definition for minor episodes). Clinical evaluations − physical examination − fundoscopy/fundusphotography − 12-lead ECG − vital signs Central laboratory − haematology (haemoglobin, leucocytes, thrombocytes, haematocrit, differential counts and erythrocytes) − biochemistry (creatinine, total protein, alanine aminotransferase, aspartat aminotransferase, alkaline phosphatase, sodium, potassium, albumin, and total bilirubin) − lipid profile (low density lipoproteins (LDL), high density lipoproteins (HDL), triglyceride and total cholesterol) − urinary albumin-to-creatinine ratio assessed in spot urine − urine by sticks (tests for blood, protein and ketones). Body weight. Insulin dose. |
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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.8.3 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | Information not present in EudraCT |
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 |
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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |