Type 2 Diabetes MedDRA version: 13.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe CHF(NYHA Class III or IV), coronary artery bypass surgery, or angioplasty, or is 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 excluded medication within 3 months prior to screening: Insulin, Thiazolidinediones, Alpha-glucosidase inhibitors, Meglitinides, Byetta bid, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (exenatide LAR minus insulin glargine) is less than zero. Non inferiority will be concluded if the upper limit of the confidence interval is 0.0% and <0.3%.;Secondary Objective: 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 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 contril, safety, and tolerability. -1,5-anhydroglucitol (1,5-AG).;Primary end point(s): Change in HbA1c from baseline to week 26. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Netherlands, Spain
Outcome results
None listed