Diabetes Type 2 Clinical Trial
— DURATION-NEO-2Official title:
A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
| Verified date | July 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.
| Status | Completed |
| Enrollment | 365 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - At least 18 years old - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.1% to 11.0%, inclusive, at screening - Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening - Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening - Body mass index of <45 kg/m2 at screening - Has been treated with a stable regimen of =1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening) Exclusion Criteria: - History of pancreatitis or triglycerides >=500 mg/dL - Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either - History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min - Active cardiovascular disease - Presence or history of severe congestive heart failure - Central nervous system disease, including epilepsy - Liver disease - History of severe gastrointestinal diseases - Clinically significant malignant disease - Repeated severe hypoglycemia within the last 6 months - Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog - Any DPP-4 inhibitor within 3 months prior screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Buena Park | California |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Burke | Virginia |
| United States | Research Site | Carrolton | Texas |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chino | California |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clayton | North Carolina |
| United States | Research Site | Corpus Christi | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Encinitas | California |
| United States | Research Site | Eugene | Oregon |
| United States | Research Site | Evanston | Illinois |
| United States | Research Site | Franklin | Ohio |
| United States | Research Site | Greenbrae | California |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Hartsdale | New York |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Katy | Texas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | North Hollywood | California |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Oxon Hill | Maryland |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Reseach Site | Rapid City | South Dakota |
| United States | Research Site | Salisbury | North Carolina |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | St. Petersburg | Florida |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | West Hills | California |
| United States | Research Site | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 | Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests. | Baseline to Week 28 | No |
| Secondary | Percentage of Subjects Achieving HbA1c <7% at Week 28 | Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination. | Baseline to Week 28 | No |
| Secondary | Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 | The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination. | Baseline to Week 28 | No |
| Secondary | Change in Body Weight (kg) From Baseline to Week 28 | The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination. | Baseline to Week 28 | No |
| Secondary | Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) | The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or = 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate. | Baseline to Week 16 | No |
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