Clinical trial NCT01652729: Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Type 2
Keywords: Diabetes, Type 2, exenatide, Sitagliptin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
timeFrame: Baseline to Week 28
Secondary outcomes:
measure: Percentage of Subjects Achieving HbA1c <7% at Week 28
timeFrame: Baseline to Week 28
measure: Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
timeFrame: Baseline to Week 28
measure: Change in Body Weight (kg) From Baseline to Week 28
timeFrame: Baseline to Week 28
measure: Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Buena Park
country: United States
facility: Research Site
state: California
city: Chino
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: North Hollywood
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Oxon Hill
country: United States
facility: Research Site
state: Maryland
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Hartsdale
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Clayton
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Mooresville
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Franklin
country: United States
facility: Research Site
state: Ohio
city: Marion
country: United States
facility: Research Site
state: Ohio
city: Yukon
country: United States
facility: Research Site
state: Oklahoma
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Reseach Site
state: South Dakota
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Carrolton
country: United States
facility: Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Katy
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Peter Ohman
role: STUDY_CHAIR
References:
citation: Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
citation: Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.