A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: sitagliptin

Drug: exenatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00477581

BCA403

Details and patient eligibility

About

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.

Enrollment

102 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Treatment with metformin for at least 2 months
Has HbA1c 7.0% to 11.0%, inclusive, at screening
Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy

Exclusion Criteria

Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
Received any study medication or participated in any type of clinical trial within 30 days prior to screening
Has donated blood within 60 days of screening visit or is planning to donate blood during the study
Treated with any of the following medications:
- Sulfonylurea or Thiazolidinedione within 3 months of screening;
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
- Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
- 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;