Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Exenatide once weekly suspension; Drug: Exenatide twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652716

MB001-003 (Other Identifier)

BCB118

Details and patient eligibility

About

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.

Enrollment: 377 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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377 participants in 2 patient groups

Exenatide once weekly suspension

Experimental group

Description:

Exenatide suspension 2 mg weekly subcutaneous injection

Treatment:

Drug: Exenatide once weekly suspension

Exenatide twice daily (BID)

Active Comparator group

Description:

Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Treatment:

Drug: Exenatide twice daily