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 | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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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 the efficacy of SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor in controlling glycaemia with respect to change from baseline in HbA_1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA_1c after 26 weeks of treatment between SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor and insulin glargine once daily + metformin ± DPP-4 inhibitor to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.
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E.2.2 | Secondary objectives of the trial |
To confirm superiority of SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor over insulin glargine once daily + metformin ± DPP-4 inhibitor after 26 weeks of treatment in terms of: • Treatment emergent severe or minor hypoglycaemic episodes • Fasting plasma glucose (FPG) analysed at a central laboratory • Within-subject variability in pre-breakfast self-measured plasma glucose (SMPG) • Frequency of responders for HbA_1c (< 7.0%) without hypoglycaemic episodes To compare efficacy and safety in terms of: • 9-point profile self measured plasma glucose (SMPG) • 1-point profile (SMPG) for dose adjustments • Frequency of responders for HbA_1c • Adverse events • Hypoglycaemic episodes • Clinical and laboratory assessments • Insulin antibodies • Insulin dose • Body weight • Patient reported outcome (PRO)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days). • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, α-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: − Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) − Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling − DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling − α-glucosidase-inhibitors (Acarbose): minimum half of the daily maximal dose or maximum tolerated dose • HbA_1c 7.0-10.0 % (both inclusive) by central laboratory analysis • BMI ≤ 45.0 kg/m²
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E.4 | Principal exclusion criteria |
• Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period • Known or suspected allergy to any of the trial products or related products • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change from baseline in HbA_1c after 26 weeks of treatment • Change from baseline in FPG after 26 weeks of treatment • Within-subject variability in pre-breakfast self-measured plasma glucose (SMPG) after 26 weeks of treatment • Responder without hypoglycaemic episodes (HbA_1c <7.0%) at end of trial without severe or minor hypoglycaemic episodes |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | 11 |
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 | 11 |