E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
|
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 efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy compared to placebo after 24 weeks of treatment. |
|
E.2.2 | Secondary objectives of the trial |
- To assess the effects of taspoglutide versus placebo on body weight. - To assess the effects of taspoglutide versus placebo on additional parameters of diabetes control and CV risk factors including lipid profile. - To assess the safety and tolerability of taspoglutide versus placebo. - To describe the pharmacokinetics of taspoglutide and to estimate between-patient variability using a population PK approach. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione: Data: Titolo:RSR Project in association with BC22092 Obiettivi:
|
|
E.3 | Principal inclusion criteria |
1. Men and women, aged 18 - 75 years at screening. Women of childbearing potential will use one medically approved method of contraception during the course of the trial. 2. Patients with type 2 diabetes mellitus on metformin at a stable dose of > 1500 mg/day (or individually maximally tolerated dose) for at least 12 weeks prior to screening. 3. HbA1c: > 6.5 and < 9.5% at screening. 4. Body mass index (BMI) > 30 and < 50 kg/m2 at screening. 5. Stable weight ± 5% for at least 12 weeks prior to screening. 6. Agreement to follow a diet and exercise plan during the course of the study. 7. Ability and willingness to give written informed consent and to comply with the requirements of the study. |
|
E.4 | Principal exclusion criteria |
1. Women who are pregnant, intending to become pregnant during the study period or currently lactating females. 2. Diagnosis of or history of: a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushings Syndrome. b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months. 3. Evidence of clinically significant diabetic complications. 4. Clinically symptomatic gastrointestinal (GI) disease including, but not limited to inflammatory bowel disease, celiac disease, diabetic gastroparesis, cholelithiasis. 5. History of gastric bypass or antrectomy, gastric banding, or small and large bowel resection. 6. History of chronic pancreatitis or idiopathic acute pancreatitis. 7. Myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months. 8. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by theInvestigator. 9. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone). 10. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years. 11. Known hemoglobinopathy or chronic anemia. 12. Donation of one unit (500 mL) or more blood, significant blood loss equalling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 13. Any concurrent medical condition/disorder that, in the opinion of the Investigator, is likely: - to interfere with the patients ability to complete the entire study period or to participate in all aspects of the trial, - to require, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety data. 14. Contraindications and warnings according to the country specific label information for metformin not listed in the other exclusion criteria. 15. Known hypersensitivity to metformin or any of its components. 16. Treatment with any oral anti-diabetic medication and/or herbal/over the counter preparations, other than metformin, that may affect glycemic control within 12 weeks prior to screening. 17. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past. 18. Treatment with insulin (except during pregnancy) for more than one week within 6 months prior to screening. 19. Treatment with systemic (oral or parenteral) corticosteroids for more than 7 consecutive days within 12 weeks prior to screening 20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) and/or herbal/over the counter preparations for obesity within 12 weeks prior to screening. 21. Documented values of blood pressure above SBP > 170 mmHg and/or DBP > 105 mmHg within the past 12 weeks prior to screening. 22. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to baseline. 23. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to screening. 24. Treatment with thyroid hormones or anti-thyroid drugs which are not at a stable dose for at least 12 weeks prior to screening. et al.. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change from baseline in HbA1c after 24 weeks. |
|
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 | Yes |
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) | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 |
|
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
|
Lo studio sara` considerato concluso alla data dell`ultima visita dell`ultimo paziente che avra` completato il trattamento (incluso il follow up previsto) |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |