E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 Diabetic Patients Inadequately Controlled with Insulin |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012607 |
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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 assess the effect of rimonabant on HbA1c in patients with type 2 diabetes treated with insulin. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of rimonabant in patients with type 2 diabetes treated with insulin -on body weight -on lipid profile -on abdominal obesity; to assess the safety and tolerability of rimonabant in patients with type 2 diabetes treated with insulin |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female patients aged or equal to 18 years Type 2 diabetes as defined by WHO criteria fasting venous plasma glucose concentration or equal to 7.0 mmol/L or 2-h post-glucose load venous plasma glucose or equal to 11.1 mmol/L treated with insulin any type and regimen for at least three months insulin dose or equal to 30 U/day for at least 4 weeks with HbA1c or equal to 7 at screening Visit |
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E.4 | Principal exclusion criteria |
Presence of any clinically significant endocrine disease according to the Investigator euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to screening Visit Presence of type 1 diabetes C-peptide 1.0 ng/mL Presence of any clinically significant condition that might interfere with the evaluation of study medication Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer Laboratory abnormalities including - C-peptide 1.0 ng/mL - positive urine pregnancy test in females of childbearing potential at screening Visit - abnormal serum thyrotropin TSH levels at screening Visit - positive test for hepatitis B surface antigen and/or hepatitis C antibody at screening Visit - any relevant abnormality interfering with the efficacy or the safety assessments during the study drug administration Some medications - administration of antidiabetic drugs other than insulin within three months prior to screening Visit - administration of anti-obesity drugs sibutramine, orlistat or other drugs for weight reduction e.g., phentermine, amphetamines within three months prior to screening Visit or administration of herbal preparations for weight reduction within 30 days prior to screening Visit - administration of thyroid preparations or thyroxine except in patients on stable replacement therapy within three months prior to screening Visit - administration of systemic long-acting corticosteroids within two months or prolonged use more than one week of other systemic corticosteroids or inhaled corticosteroids if daily dosage is 1,000 g equivalent beclomethasone within 30 days prior to screening Visit - change in the treatment of dyslipidemia within two months prior to screening Visit or between screening and baseline Visits Pregnancy or breast-feeding Absence of effective contraceptive methods for females of childbearing potential |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is to evaluate HbA1c in type II diabetic patients treated with insulin |
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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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | 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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |