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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide
* Drug: sitagliptin


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: exenatide<br>* subcutaneous injection (5mcg or 10mcg), twice a day<br>* Other names: Byetta;Drug: sitagliptin<br>* oral administration (100mg), once a day in the morning<br>* Other names: Januvia;|
| Experimental: Sequence B<br> | Drug: exenatide<br>* subcutaneous injection (5mcg or 10mcg), twice a day<br>* Other names: Byetta;Drug: sitagliptin<br>* oral administration (100mg), once a day in the morning<br>* Other names: Januvia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Exenatide on postprandial glucose | To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles | 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 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exenatide, sitagliptin, Amylin, Lilly