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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide/insulin glargine | Experimental | Arm that first receives exenatide, then crosses over to insulin glargine |
|
| Insulin glargine/exenatide | Experimental | Arm that first receives insulin glargine, then crosses over to exenatide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide/insulin glargine | Drug | Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period. | Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine. | Baseline, Week 16, Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported outcomes from Baseline to the end of each 16-week period | Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires [Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument] from Baseline to the end of each 16-week exenatide or insulin glargine period |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Malone, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Westmead | New South Wales | Australia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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|
| insulin glargine/exenatide | Drug | Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks |
|
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| Baseline, Week 16, Week 32 |
| Daw Park |
| South Australia |
| Australia |
| Research Site | Fullarton | South Australia | Australia |
| Research Site | Box Hill | Victoria | Australia |
| Research Site | East Ringwood | Victoria | Australia |
| Research Site | Athens | Greece |
| Research Site | Piraeus | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Budapest | Hungary |
| Research Site | Gyula | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Veszprém | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Bari | Italy |
| Research Site | Bergamo | Italy |
| Research Site | Catania | Italy |
| Research Site | Milan | Italy |
| Research Site | Perugia | Italy |
| Research Site | Rome | Italy |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Monterrey | N.l. | Mexico |
| Research Site | Mexico City | Mexico |
| Research Site | Bydgoszcz | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Lublin | Poland |
| 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 |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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