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

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

      • Buenos Aires, Argentina
        • Research Site
      • Morón, Argentina
        • Research Site
      • Adelaide, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Asslar, Germany
        • Research Site
      • Beckum-Neubeckum, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bosenheim, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Furth im Wald, Germany
        • Research Site
      • Grevenbroich, Germany
        • Research Site
      • Hamburg-Othmarschen, Germany
        • Research Site
      • Hohenmolsen, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Neuwied, Germany
        • Research Site
      • Pohlheim, Germany
        • Research Site
      • Speyer, Germany
        • Research Site
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Ahmedabad, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Indore, India
        • Research Site
      • Jaipur, India
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Gwangju, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Ulsan, Korea, Republic of
        • Research Site
      • Coatzacoalcos, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Merida, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
      • Tampico, Mexico
        • Research Site

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
PLACEBO_COMPARATOR: 2
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Other Names:
  • exenatide-Byetta
EXPERIMENTAL: 1
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
Other Names:
  • exenatide-Byetta; sitagliptin-Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Percent)
Time Frame: Baseline to 20 Weeks
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]
Baseline to 20 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving HbA1c <=7.0%
Time Frame: Baseline to 20 Weeks
Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <7.0%
Time Frame: Baseline to 20 Weeks
Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)
Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=6.5%
Time Frame: Baseline to 20 Weeks
Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)
Baseline to 20 Weeks
Change in FSG (mmol/L)
Time Frame: Baseline to 20 Weeks
Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Change in Body Weight (kg)
Time Frame: Baseline to 20 Weeks
Change in body weight from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Change in Waist Circumference (cm)
Time Frame: Baseline to 20 Weeks
Change in waist circumference from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Waist-to-Hip Ratio
Time Frame: Baseline to 20 Weeks
Change in waist-to-hip ratio from baseline to endpoint (Week20)
Baseline to 20 Weeks
SMBG (mmol/L)
Time Frame: Baseline to 20 Weeks
7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Baseline to 20 Weeks
Change in Triglycerides (mmol/L)
Time Frame: Baseline to 20 Weeks
Change in triglycerides from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Change in HDL (mmol/L)
Time Frame: Baseline to 20 Weeks
Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Change in LDL (mmol/L)
Time Frame: Baseline to 20 Weeks
Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Change in Total Cholesterol (mmol/L)
Time Frame: Baseline to 20 Weeks
Change in total cholesterol from baseline to endpoint (Week 20)
Baseline to 20 Weeks
Incidence of Hypoglycemia (Overall)
Time Frame: Baseline to 20 Weeks
Incidence of hypoglycemic episodes experienced overall during the study
Baseline to 20 Weeks
Incidence of Severe Hypoglycemia(Overall)
Time Frame: Baseline to 20 Weeks
Incidence of severe hypoglycemia experienced overall during the study
Baseline to 20 Weeks
Incidence of Nocturnal Hypoglycemia (Overall)
Time Frame: Baseline to 20 Weeks
Incidence of nocturnal hypoglycemia experienced overall during the study
Baseline to 20 Weeks
Incidence of Confirmed Hypoglycemia(Overall)
Time Frame: Baseline to 20 Weeks
Incidence of confirmed hypoglycemia experienced overall during the study
Baseline to 20 Weeks

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

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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