E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 |
The primary objective of this extension trial is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 + insulin aspart ± metformin ± pioglitazone to insulin glargine + insulin aspart ± metformin ± pioglitazone 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 NN1250 and insulin glargine, both in combination with insulin aspart ± metformin ± pioglitazone, 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 (for Germany: implants, injectables, combined oral contraceptives, hormonal intrauterine device (IUD), sexual abstinence or vasectomised partner). 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) |
• Number of treatment emergent adverse events with an onset on or after the first day of exposure to randomised trial drug and no later than 7 days after last exposure to randomised trial drug. • Number of severe and minor treatment emergent hypoglycaemic episodes with an onset on or after the first day of exposure to randomised trial drug and not later than 7 days after last exposure to randomised trial drug. |
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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 | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |