Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide 5 mcg/exenatide 5 mcg | Experimental | Exenatide 5 mcg; then exenatide 5 mcg |
|
| Exenatide 5 mcg/exenatide 10 mcg | Experimental | Exenatide 5 mcg, then exenatide 10 mcg |
|
| Placebo | Placebo Comparator | Placebo in volumes equivalent to exenatide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 | Change in HbA1c from Baseline to Week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less | Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less | Baseline, Weeks 4, 8, 12, 16, 24 |
| Change in fasting serum glucose (FSG) from Baseline to Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Malone, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Idaho Falls | Idaho | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18803987 | Result | Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006. | |
| 22913891 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| exenatide | Drug | Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day |
|
|
| placebo | Drug | subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day |
|
Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
| Baseline, Weeks 4, 8, 12, 16, and 24 |
| Change in body weight from Baseline to Week 24 | Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between | Baseline, Weeks 4, 8, 12, 16, and 24 |
| Change in glucose measurements from Baseline to Week 24 | Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between | Baseline, Weeks 4, 8, 12, 16, 24 |
| Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 | Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between | Baseline, Weeks 4, 8, 12, 16, and 24 |
| Changes in fasting and 30, 60, 120 and 180-minute glucose measurements | Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin | Immediately before glucose load, then 30, 60, 120, and 180 minutes post |
| Indianapolis |
| Indiana |
| United States |
| Research Site | Aligarh | India |
| Research Site | Bangalore | India |
| Research Site | Chennai | India |
| Research Site | Indore | India |
| Research Site | Karnāl | India |
| Research Site | New Delhi | India |
| Research Site | Vellore | India |
| Research Site | Manati | Puerto Rico |
| Research Site | San Juan | Puerto Rico |
| Research Site | Alba Iulia | Romania |
| Research Site | Baia Mare | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Galati | Romania |
| Research Site | Oradea | Romania |
| Research Site | Târgu Mureş | Romania |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567. |
| 22236356 | Derived | Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |