A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide once weekly; Drug: exenatide twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877890

BCB108 (DURATION-5)

Details and patient eligibility

About

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has been diagnosed with type 2 diabetes mellitus

• Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening

• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening

• Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening

• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:

  • Hormone replacement therapy (female subjects)
  • Oral contraceptives (female subjects)
  • Antihypertensive agents
  • Lipid-lowering agents
  • Thyroid replacement therapy
  • Antidepressant agents
  • Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the counter antiobesity agents

Exclusion criteria

• Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog

• Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening

• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

  • Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
  • Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
  • Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
  • Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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254 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: exenatide once weekly

2

Active Comparator group

Treatment:

Drug: exenatide twice daily