E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
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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 |
The primary objective is to estimate the difference in change in HbA1c from baseline to treatment endpoint (26 weeks) between 2.0 mg exenatide LAR once weekly and insulin glargine QD (using the algorithm described by Yki- Järvinen et al. 2007) in patients with type 2 diabetes and inadequate glycemic control using Met alone or in combination with SU. |
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E.2.2 | Secondary objectives of the trial |
To compare exenatide LAR and insulin glargine with respect to
•the proportion of patients achieving HbA1c <=7% and <=6.5%. •fasting serum glucose •change in body weight •1,5-anhydroglucitol (1,5-AG) •8-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, at bedtime, and at the 0300 hour) •serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL C]) •frequency and rate of hypoglycemic events (overall, daytime, and nocturnal) in the set of patients using Met alone or in combination with SU •safety and tolerability •patient-reported health outcomes •long-term maintenance of glycemic control, safety, and tolerability.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with Type 2 diabetes 2. At least 18 years old at screening 3.Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%, inclusive. 4.Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. 5.Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening). 6.Have been treated with Met for at least 3 months and have been taking a stable dose of >=1500 mg/day immediate-release Met or extended-release Met alone for at least 8 weeks prior to screening, unless lower doses are required due to tolerability concerns. OR Have been treated with Met for at least 3 months and have been taking a stable dose of >=1500 mg/day immediate-release Met or extended-release Met alone for at least 8 weeks prior to screening, unless lower doses are required due to tolerability concerns and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening. If combined Met plus SU OAD preparations are used, the total daily dose of each component needs to meet the criteria as outlined above. 7. Females of child bearing potential should not be breast feeding, have a negative pregnancy test, do not intend to become pregnant during the study, practice reliable birth control methods. |
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E.4 | Principal exclusion criteria |
1. Have a clinically significant history of cardiac disease or presence of active CAD within the year prior to inclusion in the study, including MI, clinically significant arrhythmia, unstable angina, moderate to severe CHF(NYHA Class III or IV), coronary artery bypass surgery, or angioplasty, or expected to require coronary artery bypass surgery or angioplasty during the study. 2. Obvious clinical signs of liver disease or hepatitis. ALT or SGPT >than 3 times the upper reference range. 3. Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >= 1.5mg/dl for males, >=1.2 mg/dl for females. 4. Have active or untreated malignancy, or have been in remission from clinically significant malignancy for less than 5 years. (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer). 5. Have known hemoglobinopathy or chronic anemia (has Hb <11.5gm/dl for males, <10.5gm/dl females 6. Greater than 3 episodes of major hypoglycaemia within 6 months prior to screening. 7. Contraindication for the OAD which they are using. 8. known allergy or hypersensitivity to exenatide LAR, glargine or excipients 9.Known to have active proliferative retinopathy 10. Treatment within 4 weeks of screening with systemic glucocorticoid therapy or potent inhaled steroids with high systemic absorption 11. Used drugs for weight loss within 3 months of screening. 12. have been treated for longer than two weeks with any of the following with 3 months prior to screening insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, byetta b.id., DPPIV inhibitors, symlin. 13. Have an organ transplant 14. Have donated blood with 30 days of screening 15. have previously been involved in an exenatide LAR study 16. Have received treatment within 30 days of an unlicenced indication 17. Currently involved in another clinical study 18. Have a condition (e.g alcohol abuse) that renders them unable to understand involvement in the study or in the investigator's opinion makes them unsuitable to participate.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c from baseline to week 26. |
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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 | 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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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 | 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
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last visit of the last subject |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |