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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477581
• Other study ID #: BCA403
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2007
• Last updated: August 25, 2015
• Start date: May 2007
• Est. completion date: September 2007

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
• sitagliptin
oral administration (100mg), once a day in the morning

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Butte	Montana
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinatti	Ohio
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Eugene	Oregon
United States	Research Site	Greer	South Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Los Angeles	California
United States	Research Site	Marion	Ohio
United States	Research Site	Miami	Florida
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	Spring Valley	California
United States	Research Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No