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 | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 investigate if treat-to-target treatment with insulin detemir once-daily (OD) combined with metformin accompanied with dietary intervention is superior to treat-to-target treatment with insulin detemir OD combined with metformin without dietary intervention with respect to weight change after 26 weeks of treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other OADs. |
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E.2.2 | Secondary objectives of the trial |
• To investigate the association between weight change at 26 weeks and baseline BMI • To assess and compare efficacy after 26 weeks of treatment • To assess and compare safety and tolerability after 26 weeks of treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Type 2 diabetes (diagnosed clinically) for ≥ 6 months prior to screening • Insulin naive subjects • Current treatment: metformin monotherapy or metformin in any combination with the following OADs: insulin secretagogue (SU or glinide), DPP-4 inhibitor, α-glucosidase-inhibitors (acarbose), all with an unchanged total daily dosing for at least 3 months prior to screening • HbA1c 7.0-9.0 % (both inclusive) at screening by central laboratory analysis • BMI 25.0-45.0 kg/m2 (both inclusive) measured at screening |
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E.4 | Principal exclusion criteria |
• Use of: TZDs or Glucagon-like peptide-1 analogue (GLP-1) receptor agonists within the last 3 months prior to Visit 1 • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO inhibitors) • Anticipated initiation or change in concomitant medication known to affect weight, such as weight loss/modifying medication (e.g. sibutramine, orlistat, thyroid hormones), steroids (e.g. corticosteroids, progesterone, testosterone) and diuretics • Any conditions that the investigator judges would interfere with trial participation or evaluation of the results • Known or suspected allergy to insulin detemir or related products |
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E.5 End points |
E.5.1 | Primary end point(s) |
Weight change from baseline to end of the treatment period |
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
With or without dietary consultation |
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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 | 23 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 2 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 2 |