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 |
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 in patients with type 2 diabetes and inadequate control using Met alone or in combination with SU. Superiority of exenatide LAR with respect to change in HbA1c will be concluded if the upper limit of the 95% confidence interval for the treatment difference is less than zero. Non inferiority will be concluded if the upper limit of CI is >=0.0% and <0.3%. Hypotheses will be tested hierarchically. Heirachical testing requires no adjustment to the type 1 error rate for multiple comparisons. |
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E.2.2 | Secondary objectives of the trial |
To compare exenatide LAR and insulin glargine with respect to - proportion of patients achieving HbA1c <=7% and 6.5% -fasting serum glucose -change in body weight -8 point self monitored blood glucose profile -serum lipids, fasting triglycerides, calculated low density lipoprotein cholesterol -frequency and rate of hypoglycaemia in met alone or in combination with SU -safety and tolerability -patient reported health outcomes. -long-term maintenance of glycemic control, safety and tolerability -1,5-anhydroglucitol (1,5-AG) |
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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 |
Eli Lilly and Company has established a program, Combined Specimen Banking (CSB), to bank samples from patients enrolled in studies sponsored by the company. The Banked Samples are collected and banked for research to identify the genes and/or gene products and/or biochemical markers associated with diseases and/or response to clinical trial medication or other medication taken during the trial. For example, in Study H8O-MC-GWBR (GWBR), the samples collected from the patients may be used for research aimed at associating naturally occurring differences in the serum or plasma (proteins) or DNA (polymorphisms) with risk for diseases such as type 2 diabetes. In addition, scientific research may be aimed at identifying genetic or protein biomarkers related to the therapeutic response to exenatide or other compounds/medications the patient is taking during this study. As possible examples, research may look at DNA variants in the GLP-1 receptor and the response to medications like exenatide. |
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E.3 | Principal inclusion criteria |
1. Patients with Type 2 diabetes 2. >18 years old at screening 3. Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%, inclusive. 4. Body mass index 25 to 45kg/m2 inclusive. 5. History of stable body weight 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. 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 | 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) | 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 | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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
| 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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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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 | |
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 | 6 |