Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
This study is not yet open for participant recruitment.
Verified by Amylin Pharmaceuticals, Inc., August 2008
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00729326
  Purpose

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: sitagliptin
Drug: placebo
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide Metformin Metformin hydrochloride Dextrose Sitagliptin phosphate Sitagliptin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title: Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Test the hypothesis that twice daily exenatide will result in a lower time-averaged glucose during a 24-hour period, compared with once daily oral sitagliptin, in patients with type 2 diabetes inadequately controlled on metformin or a TZD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare exenatide and sitagliptin with respect to various pharmacodynamic measurements in subjects with type 2 diabetes mellitus. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: August 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence A: Experimental Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Drug: placebo
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: placebo
oral administration (100mg), once a day in the morning
Sequence B: Experimental Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Drug: placebo
subcutaneous injection (5mcg or 10mcg), twice a day
Drug: placebo
oral administration (100mg), once a day in the morning

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes
  • Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
  • Have a fasting glucose concentration <280 mg/dL at Visit 1
  • Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
  • Are between 18 and 70 years of age, inclusive.
  • Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
  • Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
  • Can swallow oral study drug capsule, without splitting or crushing.

Exclusion Criteria:

  • Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:

    • Are breastfeeding.
    • Test positive for pregnancy at the time of screening.
    • Intend to become pregnant during the study.
    • Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
  • Treated with any of the following medications:

    • Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
    • Alpha-glucosidase inhibitor within 2 months of screening.
    • Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
    • Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
    • Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
  • Have a history of renal transplantation or are currently receiving renal dialysis.
  • Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
  • Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
  • Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have had organ transplantation.
  • Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729326

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY(1-877-285-4559)

Locations
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers: H8O-US-GWCV
Study First Received: August 4, 2008
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00729326  
Health Authority: United States: Institutional Review Board

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes
exenatide
sitagliptin
Amylin
Lilly
metformin
thiazolidinedione

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
2,4-thiazolidinedione
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009