E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 anti exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide in clinical trials H80-MC-GWAO and H80-MC-GWAP or GWAT (114). |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the impact of anti-exenatide antibodies on patients' safety and efficacy as assessed by incidence of adverse events and change in HbA1c. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with Type 2 diabetes 2. Previous exposure to exenatide for at least 3 months in previous studies GWAO , GWAP or GWAT (114). 3. Have interrupted their exenatide treatment for a period of 2 months to 2.5 years. 4. HbA1c of <= 10.5% |
|
E.4 | Principal exclusion criteria |
1. Are Lilly or Amylin employees. 2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 3. Have previously completed or withdrawn from this study. 4. females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) only. • Are breastfeeding. • Test positive for pregnancy at the time of enrollment based on a blood serum pregnancy test. • Intend to become pregnant during the study. • Have not practiced a reliable method of birth control for 3 months prior to screening. • Do not agree to continue to use a reliable method of birth control during the study, as determined by the investigator. 5. Has poorly controlled blood pressure (>=180 mm Hg, systolic value; >=110 mm Hg, diastolic value). 6. Have a known allergy to exenatide. 7. Have taken marketed exenatide during the interim period between studies GWAO, GWAP, or GWAT and the current study. 8. Have a clinically significant coronary artery disease history or presence of Class III or IV cardiac disease , coronary artery bypass surgery, or angioplasty within the year prior to inclusion in the study; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. 9. Have a history of renal transplantation or are currently receiving renal dialysis or have an estimated creatinine clearance of <50 mL/min. 10. Have obvious clinical signs or symptoms of liver disease, chronic hepatitis, or (ALT/SGPT) >2.5 times the upper limit of the reference range. 11. Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar otc medications) within 3 months of screening. 12. Are currently treated with any of the following excluded medications: • Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride and chronic macrolide antibiotics. 13. Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. 14. Have had an organ transplant. 15. Use insulin with daily dosage exceeding 1 U/kg
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Treatment-emergent anti-exenatide antibodies titre and relationship to adverse events particularly allergy and hypersensitivity. |
|
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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | 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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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 | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |