Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, sitagliptin, Amylin, Lilly
Brief summary
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.
Interventions
DRUGexenatide
subcutaneous injection (5mcg or 10mcg), twice a day
DRUGsitagliptin
oral administration (100mg), once a day in the morning
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Exenatide on postprandial glucose | 28 days | To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles | 28 days | To compare the effect of exenatide to the effect of sitagliptin on the following endpoints in subjects with type 2 diabetes mellitus: postprandial glucose, insulin, insulin secretion rate, glucagon, and triglycerides; gastric emptying, as assessed by the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles |
Countries
United States
Outcome results
None listed