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 | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049746 |
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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 compare the glycaemic control, measured as HbA1c, of insulin detemir given once daily with that of NPH insulin given once daily as add-on to current OAD treatment, in subjects with type 2 diabetes after a 20 week treatment period |
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E.2.2 | Secondary objectives of the trial |
The following is an abreviated version of the secondary objectives. For further details please refer to the protocol.
If both insulin detemir treatments, insulin detemir given in the morning and insulin detemir given in the evening, are shown to be non-inferior to NPH insulin given once daily with regard to HbA1c, the secondary objective is to compare the glycaemic control, measured as HbA1c, of insulin detemir given in the morning with that of insulin detemir given in the evening, as add-on to OAD(s) after a 20 week treatment period.
If both insulin detemir treatments are shown to be non-inferior to NPH insulin with regard to HbA1c, insulin detemir in the morning will be compared to insulin detemir in the evening in terms of the same parameters as mentioned above |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). 2. Type 2 diabetes according to clinical judgement. 3. Duration of type 2 diabetes ≥12 months. 4. Insulin naïve subjects. Previous short-term insulin treatment (seven days or less) is allowed. 5. Currently on any oral antidiabetic drug (OAD) ≥ 3 months according to the following: • Countries where the combination of insulin and TZD is not approved: OAD monotherapy, except TZD or alpha-glucosidase inhibitors OAD combination therapy, except the combination of TZD and alpha-glucosidase inhibitors • Countries where the combination of insulin and TZD is approved: Any OAD treatment except monotherapy with alpha-glucosidase inhibitors 6. The dose of the individual OAD must be either highest tolerated dose or at least half maximum recommended dose according to local labelling ≥ 3 months prior to screening. 7. The OAD dose(s) must be unchanged for the last month prior to screening. 8. Age ≥ 18 years, females and males. 9. Body mass index (BMI) ≤ 40.0 kg/m2. 10. HbA1c ≥ 7.5 and ≤11.0% at screening based on analysis from the central laboratory. 11. Able and willing to use daily injections of insulin for the entire trial period. 12. Able and willing to perform self-monitoring of plasma glucose according to the protocol
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E.4 | Principal exclusion criteria |
1. Previous participation in this trial. Participation is defined as screened. 2. Previous acute treatment with insulin > 7 days. 3. Treatment with TZD and/or other OAD(s) which does not adhere to the approved labelling for the respective country. 4. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors. 5. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months. 6. Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator. 7. Any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial. 8. Uncontrolled hypertension (treated or untreated) as judged by the investigator. 9. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. 10. Known or suspected allergy to trial product(s) or related products. 11. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods. In Denmark and France barrier methods are not accepted as adequate contraceptives. 12. The receipt of any investigational drug within one month prior to this trial. 13. Any condition that the Investigator feels would interfere with trial participation or evaluation of results. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: • HbA1c after 20 weeks of treatment.
Secondary endpoints: Efficacy • Proportion of subjects achieving HbA1c ≤7.0% after 20 weeks of treatment. • Proportion of subjects achieving HbA1c ≤7.0% after 20 weeks of treatment without symptomatic hypoglycaemia with a plasma glucose value < 4.0 mmol/L (< 72 mg/dL) or any single plasma glucose value < 3.1 mmol/L (< 56 mg/dL), in the last four weeks of treatment. • FPG (central laboratory analysis) after 12 and 20 weeks of treatment. • Within-subject variation of SMPG before breakfast and dinner at baseline and after eight and 20 weeks of treatment. • 9-point SMPG profiles during the trial.
Safety • Incidence of hypoglycaemic episodes (all, minor, major and symptoms only) during the trial; nocturnal (11 pm–6 am) and over the entire day (24 hours). • Incidence of adverse events during the trial. • Laboratory assessments (haematology, biochemistry and lipids), fundoscopy/fundusphotography and vital signs after 20 weeks of treatment.
Others • Body weight change after 20 weeks of treatment. • Insulin doses during the trial. • Level of serum insulin and C-peptide in insulin naïve subjects at baseline (Visit 2). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |