- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729326
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
March 20, 2015 updated by: AstraZeneca
Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence A
|
subcutaneous injection (5mcg or 10mcg), twice a day
Other Names:
oral administration (100mg), once a day in the morning
Other Names:
subcutaneous injection (5mcg or 10mcg), twice a day
oral administration (100mg), once a day in the morning
|
Experimental: Sequence B
|
subcutaneous injection (5mcg or 10mcg), twice a day
Other Names:
oral administration (100mg), once a day in the morning
Other Names:
subcutaneous injection (5mcg or 10mcg), twice a day
oral administration (100mg), once a day in the morning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Time-averaged Glucose During a 24 Hour Period
Time Frame: baseline and 8 Weeks
|
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
|
baseline and 8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Two-hour Postprandial Glucose After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Fasting Blood Glucose After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Triglyceride AUC After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial C-peptide AUC After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
|
baseline and 8 Weeks
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Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
|
baseline and 8 Weeks
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Change in Postprandial Insulin AUC After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Time Frame: baseline and 8 Weeks
|
Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
|
baseline and 8 Weeks
|
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Time Frame: baseline and 8 Weeks
|
Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
|
baseline and 8 Weeks
|
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Time Frame: 4 Weeks
|
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
|
4 Weeks
|
Episodes of Hypoglycemia (Baseline to Week 4)
Time Frame: 4 weeks
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Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
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4 weeks
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Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Time Frame: 8 weeks
|
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
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8 weeks
|
Episodes of Hypoglycemia (Week 4 to Week 8)
Time Frame: 8 weeks
|
Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
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8 weeks
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Percentage of Patients Experiencing Hypoglycemia (Overall)
Time Frame: 4 weeks and 8 weeks
|
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
|
4 weeks and 8 weeks
|
Episodes of Hypoglycemia (Overall)
Time Frame: 4 weeks and 8 weeks
|
Number of episodes of hypoglycemia experienced overall during the study
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4 weeks and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
August 4, 2008
First Submitted That Met QC Criteria
August 6, 2008
First Posted (Estimate)
August 7, 2008
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
March 20, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Anti-Obesity Agents
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
- Exenatide
Other Study ID Numbers
- H8O-US-GWCV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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