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 purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental |
| |
| Sequence B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection (5mcg or 10mcg), twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Exenatide on postprandial glucose | To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles | To compare the effect of exenatide to the effect of sitagliptin on the following endpoints in subjects with type 2 diabetes mellitus: postprandial glucose, insulin, insulin secretion rate, glucagon, and triglycerides; gastric emptying, as assessed by the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles |
Not provided
Inclusion Criteria:
Treatment with metformin for at least 2 months
Has HbA1c 7.0% to 11.0%, inclusive, at screening
Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
Exclusion Criteria
Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
Received any study medication or participated in any type of clinical trial within 30 days prior to screening
Has donated blood within 60 days of screening visit or is planning to donate blood during the study
Treated with any of the following medications:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18786299 | Derived | DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008 Oct;24(10):2943-52. doi: 10.1185/03007990802418851. Epub 2008 Sep 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sitagliptin | Drug | oral administration (100mg), once a day in the morning |
|
|
| 28 days |
| Spring Valley |
| California |
| United States |
| Research Site | Miami | Florida | United States |
| Research Site | Pembroke Pines | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Indianapolis | Indiana | 46260 | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Marion | Ohio | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Corpus Christi | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| 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 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided