E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of obesity in patients with Type II diabetes |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the weight-reducing efficacy of 3 fixed doses of ATL-962 with that of placebo in obese patients with Type II diabetes when prescribed a hypocaloric diet.
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E.2.2 | Secondary objectives of the trial |
To compare the effect of 3 fixed doses of ATL 962 with that of placebo on other clinical parameters associated with obesity in obese patients with Type II diabetes when prescribed a hypocaloric diet.
To compare the safety and tolerability of 3 fixed doses of ATL-962 with that of placebo in obese patients with Type II diabetes when prescribed a hypocaloric diet.
To compare the safety and tolerability of 3 fixed doses of ATL-962 with that of orlistat in obese patients with Type II diabetes when prescribed a hypocaloric diet.
To compare the efficacy of orlistat with that of placebo on clinical parameters associated with obesity in obese patients with Type II diabetes when prescribed a hypocaloric diet.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. The patient has provided written informed consent. 2. Male or female patients aged between 18 and 65 years of age (inclusive). Female patients must be either: - post-menopausal (cessation of menses for at least one year) - sterilised (hysterectomy, bilateral tubal ligation, bilateral oophorectomy) - committed to sexual abstinence - willing to use consistently and correctly one of the following contraceptive methods: • Implants of levonorgestrel inserted for at least one month prior to the study drug administration, but not beyond the third successive year following insertion • Injectable progestogen administered for at least one month prior to the study drug administration and administered for one month following study completion • An intrauterine device, inserted at least one monthly cycle prior to study drug administration • Vasectomised partner • A combination of oral contraception with spermicidal covered condom. There are no data on the possible interactions between ATL-962 and oral contraceptives, therefore oral contraceptives must not be used as the sole form of contraception. Patients must not become pregnant for at least two weeks after cessation of study drug intake. 3. The patient has a body mass index (BMI) >28 kg/m² and <45 kg/m² 4. The patient has been diagnosed with Type II diabetes >3 months prior to the screening visit and treated on an outpatient basis. 5. The patient has a HbA1c >6% and <10% and has been maintained on the same dose of metformin for at least 3 months. |
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E.4 | Principal exclusion criteria |
1. Female patients who are pregnant or lactating (A serum pregnancy test will be performed in females of child bearing potential at the screening visit and a urine pregnancy test at all subsequent visits) 2. Significant weight loss in the 3 months prior to screening 3. Weight gain during run-in period outside the pre-defined limit of 0.1Kg 4. History of any serious systemic disease with the exception of Type II diabetes, controlled hypertension (SBP <155 mmHg, DBP <90 mmHg), controlled mild asthma, controlled primary hypothyroidism (TSH ≤ 1.5 times upper limit of normal at screening). 5. Requires medication that could interfere with the evaluation of the study drug (see section 3.3.6 of the protocol) 6. Clinically significant abnormalities on ECG 7. Evidence of impaired renal function (plasma creatinine >180 µmol/l) or impaired hepatic function, as shown by, but not limited to, AST or ALT ≥2 times the upper limit of normal at baseline 8. History of GI disorders, e.g. chronic inflammatory bowel disease, pancreatitis, pancreatic lipase deficiency, lactose intolerance or partial ileal bypass. 9. Evidence of GI disease that limits drug absorption. 10. Previous surgery for weight reduction. 11. Evidence of active malignant disease. Patients who have been disease free for at least 5 years may be included. 12. HIV or hepatitis C infection (Tests for HIV and hepatitis C will not be a study requirement). 13. History of anaphylaxis associated with medicinal products 14. Known or suspected hypersensitivity to ATL-962 or any of the excipients or other compounds related to this class of therapeutic agent. 15. Bulimia or evidence of laxative abuse. 16. Taken drugs capable of influencing weight loss in the last 6 months or orlistat at any time in the past 17. History of alcohol or substance abuse 18. Received treatment with other investigational agents or devices within the previous 3 months, has planned use of other investigational drugs or devices, or was previously enrolled in this trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute weight loss compared to baseline (i.e. randomisation visit) |
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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 | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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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.8.5 | 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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |