E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity in patients with type 2 diabetes mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
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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 |
1. To assess the effects of taranabant on body weight after 36 weeks of treatment.
2. To assess the effects of taranabant on hemoglobin A1c (HbA1c) after 36 weeks of treatment. 3. To assess the safety and tolerability of taranabant during base and extension studies.
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E.2.2 | Secondary objectives of the trial |
To assess the effects of treatment with taranabant 0.5-, 1- or 2-mg on: 1. body weight after 24 and 52 weeks. 2. hemoglobin A1c (HbA1c) after 24 and 52 weeks. 3. FPG, insulin and insulin sensitivity after 24, 36, and 52 weeks. 4. biochemical markers (TG, HDL-C, non-HDL-C, LDL-C, TC, adiponectin and CRP) after 24, 36, and 52 weeks. 5. body weight and HbA1c in subgroups of patients not on anti-hyperglycemic therapy or on metformin monotherapy at randomization. 6. waist circumference after 24, 36, and 52 weeks. 7. blood pressure after 24, 36, and 52 weeks. 8. the proportion of patients requiring glycemic rescue therapy after 24, 36 weeks and 52 weeks. 9. Quality-of-life and health economic patient-reported outcomes (PRO) after 24, 36 and 52 weeks. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men (minimum 25%; targeting 40%) and women with a body mass index (BMI) between 27 kg/m2 and 43 kg/m2, inclusive. 2. Patients ≥18 and </=75 years of age with type 2 diabetes mellitus (T2DM) who are either: (1) not on antihyperglycemic medication (i.e. newly diagnosed with T2DM or treated by diet alone during the past 6 months); or (2) on a stable dose of metformin (≥1500 mg/day, unless the maximum tolerated dose is <1500 mg/day) for at least 12 weeks may participate. 3. Patients will have an HbA1c between 7.0% and 10.0%, inclusive. |
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E.4 | Principal exclusion criteria |
1. Patient has a history of type 1 diabetes mellitus [confirmed with a C-peptide <0.8 ng/mL (0.26 nmol/L)] or a history of ketoacidosis.
2. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder).
3. Patient has a history of seizures or is at high risk of developing seizures (e.g., those with history of brain tumors or severe head trauma or intracranial hemorrhage). 4. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
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 | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 21 |