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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00477581
First received: May 21, 2007
Last updated: June 4, 2014
Last verified: June 2014

May 21, 2007
June 4, 2014
May 2007
September 2007   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00477581 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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 A
    Interventions:
    • Drug: exenatide
    • Drug: sitagliptin
  • Experimental: Sequence B
    Interventions:
    • Drug: exenatide
    • Drug: sitagliptin
DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008 Oct;24(10):2943-52. Epub 2008 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
September 2007
September 2007   (final data collection date for primary outcome measure)

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;
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477581
BCA403
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP