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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Morón, Argentina
        • Research Site
  • Australia
      • Adelaide, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
  • Germany
      • 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
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • India
      • Ahmedabad, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Coimbatore, India
        • Research Site
      • Indore, India
        • Research Site
      • Jaipur, India
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Research Site
      • Gwangju, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Ulsan, Korea, Republic of
        • Research Site
  • Mexico
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: 2
Drug: exenatide and placebo
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
Drug: exenatide and sitagliptin
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings