- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870194
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
March 20, 2015 updated by: AstraZeneca
The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
255
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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Buenos Aires, Argentina
- Research Site
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Morón, Argentina
- Research Site
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Adelaide, Australia
- Research Site
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Geelong, Australia
- Research Site
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Melbourne, Australia
- Research Site
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Aschaffenburg, Germany
- Research Site
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Asslar, Germany
- Research Site
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Beckum-Neubeckum, Germany
- Research Site
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Berlin, Germany
- Research Site
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Bosenheim, Germany
- Research Site
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Essen, Germany
- Research Site
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Falkensee, Germany
- Research Site
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Furth im Wald, Germany
- Research Site
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Grevenbroich, Germany
- Research Site
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Hamburg-Othmarschen, Germany
- Research Site
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Hohenmolsen, Germany
- Research Site
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Leipzig, Germany
- Research Site
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Neuwied, Germany
- Research Site
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Pohlheim, Germany
- Research Site
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Speyer, Germany
- Research Site
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Athens, Greece
- Research Site
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Thessaloniki, Greece
- Research Site
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Ahmedabad, India
- Research Site
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Bangalore, India
- Research Site
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Coimbatore, India
- Research Site
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Indore, India
- Research Site
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Jaipur, India
- Research Site
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Daegu, Korea, Republic of
- Research Site
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Gwangju, Korea, Republic of
- Research Site
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Seoul, Korea, Republic of
- Research Site
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Ulsan, Korea, Republic of
- Research Site
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Coatzacoalcos, Mexico
- Research Site
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Guadalajara, Mexico
- Research Site
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Merida, Mexico
- Research Site
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Monterrey, Mexico
- Research Site
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Tampico, Mexico
- 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 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Present with type 2 diabetes
Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
- 100 mg/day sitagliptin and
- ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
- Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
- Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have previously completed or withdrawn from this study or any other study investigating exenatide.
- Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
- Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
Are currently treated with any of the following excluded medications:
- Thiazolidinediones (TZD) within 3 months of screening.
- Sulfonylurea (SU) within 3 months of screening.
- Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
- Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
- Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
- Exogenous insulin within the 3 months prior to screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
- Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
- Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.
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: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 2
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exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Other Names:
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EXPERIMENTAL: 1
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exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c (Percent)
Time Frame: Baseline to 20 Weeks
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Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]
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Baseline to 20 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Achieving HbA1c <=7.0%
Time Frame: Baseline to 20 Weeks
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Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
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Baseline to 20 Weeks
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Percentage of Patients Achieving HbA1c <7.0%
Time Frame: Baseline to 20 Weeks
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Percentage of patients whose baseline HbA1c was >=7.0%
achieving HbA1c <7.0% at endpoint (Week 20)
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Baseline to 20 Weeks
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Percentage of Patients Achieving HbA1c <=6.5%
Time Frame: Baseline to 20 Weeks
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Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)
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Baseline to 20 Weeks
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Change in FSG (mmol/L)
Time Frame: Baseline to 20 Weeks
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Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Change in Body Weight (kg)
Time Frame: Baseline to 20 Weeks
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Change in body weight from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Change in Waist Circumference (cm)
Time Frame: Baseline to 20 Weeks
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Change in waist circumference from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Waist-to-Hip Ratio
Time Frame: Baseline to 20 Weeks
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Change in waist-to-hip ratio from baseline to endpoint (Week20)
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Baseline to 20 Weeks
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SMBG (mmol/L)
Time Frame: Baseline to 20 Weeks
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7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
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Baseline to 20 Weeks
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Change in Triglycerides (mmol/L)
Time Frame: Baseline to 20 Weeks
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Change in triglycerides from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Change in HDL (mmol/L)
Time Frame: Baseline to 20 Weeks
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Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Change in LDL (mmol/L)
Time Frame: Baseline to 20 Weeks
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Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Change in Total Cholesterol (mmol/L)
Time Frame: Baseline to 20 Weeks
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Change in total cholesterol from baseline to endpoint (Week 20)
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Baseline to 20 Weeks
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Incidence of Hypoglycemia (Overall)
Time Frame: Baseline to 20 Weeks
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Incidence of hypoglycemic episodes experienced overall during the study
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Baseline to 20 Weeks
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Incidence of Severe Hypoglycemia(Overall)
Time Frame: Baseline to 20 Weeks
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Incidence of severe hypoglycemia experienced overall during the study
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Baseline to 20 Weeks
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Incidence of Nocturnal Hypoglycemia (Overall)
Time Frame: Baseline to 20 Weeks
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Incidence of nocturnal hypoglycemia experienced overall during the study
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Baseline to 20 Weeks
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Incidence of Confirmed Hypoglycemia(Overall)
Time Frame: Baseline to 20 Weeks
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Incidence of confirmed hypoglycemia experienced overall during the study
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Baseline to 20 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2009
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
March 25, 2009
First Submitted That Met QC Criteria
March 26, 2009
First Posted (ESTIMATE)
March 27, 2009
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-CR-GWDK
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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