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Completed

NCT Number: NCT00477581

A 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

exenatide

Drug

subcutaneous injection (5mcg or 10mcg), twice a day

Other names: Byetta

Sitagliptin

Drug

oral administration (100mg), once a day in the morning

Other names: Januvia

Primary outcomes

  1. Effect of Exenatide on postprandial glucose

    Time frame: 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 outcomes

  1. Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 23, 2007
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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