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 (DURATION-NEO-2)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Type 2

Treatments: Drug: Exenatide once weekly suspension; Drug: Placebo; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652729

BCB120

MB001-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 3 patient groups, including a placebo group

Exenatide once weekly suspension

Experimental group

Description:

Exenatide once weekly suspension 2mg subcutaneous injection

Treatment:

Drug: Exenatide once weekly suspension

Sitagliptin 100mg

Active Comparator group

Description:

Overencapsulated Sitagliptin 100mg oral tablet once daily

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Description:

Placebo oral capsule once daily

Treatment:

Drug: Placebo