Diabetes Mellitus, Type 2 Clinical Trial
— DURATION-NEO-1Official title:
A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus
| Verified date | May 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once
weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with
type 2 diabetes mellitus.
To examine the long-term (52 weeks of treatment) safety and effect on glucose control of
exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
| Status | Completed |
| Enrollment | 377 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - At least 18 years old - Diagnosed with type 2 diabetes mellitus - HbA1c 7.1 to 11%, inclusive, at screening - Fasting plasma glucose <280 mg/dL (15.5 mmol/L) - Body mass index (BMI) <=45 kg/m2, inclusive, at screening - Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents Exclusion Criteria: - History of pancreatitis or triglycerides >=500 mg/dL - Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either - Active cardiovascular disease - Presence of congestive heart failure - Liver disease - History of severe gastrointestinal diseases - Repeated severe hypoglycemia within the last 6 months - Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog - Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Butte | Montana |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Coral Gables | Florida |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Elkridge | Maryland |
| United States | Research Site | Endwell | New York |
| United States | Research Site | Escondido | California |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Harleysville | Pennsylvania |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Hyattsville | Maryland |
| United States | Research Site | Kissimmee | Florida |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Lomita | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Murray | Utah |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | New Bedford | Massachusetts |
| United States | Research Site | New Windsor | New York |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olympia | Washington |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Oviedo | Florida |
| United States | Research Site | Paducah | Kentucky |
| United States | Research Site | Palm Harbor | Florida |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Ponte Vedra | Florida |
| United States | Research Site | Port Gibson | Mississippi |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Spring Valley | California |
| United States | Research Site | Troy | Michigan |
| United States | Research Site | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 | The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. | Baseline to Week 28 | |
| Secondary | Percentage of Subjects Achieving HbA1c <7% at Week 28 | Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination | Baseline to Week 28 | |
| Secondary | Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 | Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination | Baseline to Week 28 | |
| Secondary | Change in Body Weight (kg) From Baseline to Week 28 | Change in body weight (kg) from baseline to Week 28/Study Termination. | Baseline to Week 28 | |
| Secondary | Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 | Change in 2-hour postprandial glucose concentrations from baseline to Week 16. | Baseline to Week 16 |
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