A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00477581
First received: May 21, 2007
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: sitagliptin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the effect of exenatide to the effect of sitagliptin on various pharmacodynamic measurements in subjects with type 2 diabetes mellitus. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 102 |
| Study Start Date: | May 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence A |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Name: Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Name: Januvia
|
| Experimental: Sequence B |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Name: Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Name: Januvia
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477581
Locations
| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| Research Site | |
| Spring Valley, California, United States | |
| United States, Florida | |
| Research Site | |
| Miami, Florida, United States | |
| Research Site | |
| Pembroke Pines, Florida, United States | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States | |
| Research Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States | |
| United States, North Carolina | |
| Research Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Research Site | |
| Cincinatti, Ohio, United States | |
| Research Site | |
| Marion, Ohio, United States | |
| United States, Oregon | |
| Research Site | |
| Eugene, Oregon, United States | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, South Carolina | |
| Research Site | |
| Charleston, South Carolina, United States | |
| Research Site | |
| Greer, South Carolina, United States | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States | |
| Research Site | |
| Corpus Christi, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00477581 History of Changes |
| Other Study ID Numbers: | BCA403 |
| Study First Received: | May 21, 2007 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes exenatide sitagliptin Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Sitagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013