A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

March 19, 2015 updated by: AstraZeneca

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

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.
235

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 3

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

  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Blackburn, United Kingdom
        • Research Site
      • Bolton, United Kingdom
        • Research Site
      • Bournemouth, United Kingdom
        • Research Site
      • Bristol, United Kingdom
        • Research Site
      • Chippenham, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Haywards Heath, United Kingdom
        • Research Site
      • High Wycombe, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • Kent, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • Livingstone, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Middlesborough, United Kingdom
        • Research Site
      • Norwich, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Oldham, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Rochdale, United Kingdom
        • Research Site
      • Salford, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site
      • Torquay, United Kingdom
        • Research Site
      • Wakefield, United Kingdom
        • Research Site
      • Wirral, United Kingdom
        • 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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
  • HbA1c between 7.5% and 10.0%.
  • BMI >27.

Exclusion Criteria:

  • Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 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: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: 1
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Names:
  • Byetta
Active Comparator: 2
Drug: insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Other Names:
  • Lantus

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
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Time Frame: 26 weeks
Composite endpoint evaluating effect of treatment on glycemic control and weight
26 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
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
Time Frame: 26 weeks
Composite endpoint evaluating effect of treatment on glycemic control and weight
26 weeks
Change in Fasting Serum Glucose
Time Frame: 26 weeks
Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
26 weeks
Percent of Patients Achieving HbA1c ≤ 7.4%
Time Frame: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Percent of Patients Achieving HbA1c < 7%
Time Frame: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Percent of Patients Achieving HbA1c < 6.5%
Time Frame: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Change in 7 Point Self Monitored Blood Glucose Profile
Time Frame: 26 weeks
Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
26 weeks
Change in Body Mass Index (BMI)
Time Frame: 26 weeks
Change in BMI from baseline to endpoint
26 weeks
Change in Waist Circumference
Time Frame: 26 Weeks
Change in waist circumference from baseline to endpoint
26 Weeks
Change in Waist-to-hip Ratio
Time Frame: 26 weeks
Change in waist-to-hip ratio from baseline to endpoint
26 weeks
Change in Body Weight
Time Frame: 26 weeks
Change in body weight from baseline to endpoint
26 weeks
Percent Change in Body Weight
Time Frame: 26 Weeks
Percent change in baseline body weight at endpoint
26 Weeks
Percent of Patients Achieving 5% Weight Loss
Time Frame: 26 weeks
Percent of patients who lost at least 5% of baseline body weight at endpoint
26 weeks
Percent of Patients Achieving 10% Weight Loss
Time Frame: 26 weeks
Percent of patients who lost at least 10% of baseline body weight at endpoint
26 weeks
Change in Systolic Blood Pressure
Time Frame: 26 weeks
Change in systolic blood pressure from baseline to endpoint
26 weeks
Change in Diastolic Blood Pressure
Time Frame: 26 weeks
Change in diastolic blood pressure from baseline to endpoint
26 weeks
Change in Fasting Serum Total Cholesterol (TC)
Time Frame: 26 weeks
Change in TC from baseline to endpoint
26 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Time Frame: 26 weeks
Change in HDL cholesterol from baseline to endpoint
26 weeks
Change in TC to HDL Cholesterol Ratio
Time Frame: 26 weeks
Change in TC to HDL cholesterol ratio from baseline to endpoint
26 weeks
Change in Fasting Serum Triglycerides
Time Frame: 26 weeks
Change in fasting serum triglycerides from baseline to endpoint
26 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Time Frame: 26 weeks
Change in LDL cholesterol from baseline to endpoint
26 weeks
Change in Apolipoprotein-B
Time Frame: 26 weeks
Change in apolipoprotein-B from baseline to endpoint
26 weeks
Incidence of Hypoglycemic Episodes
Time Frame: 26 weeks
Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
26 weeks
Incidence of Nocturnal Hypoglycemic Episodes
Time Frame: 26 weeks
Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
26 weeks
Incidence of Severe Hypoglycemic Episodes
Time Frame: 26 weeks
Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
26 weeks
Hypoglycemic Rate Per 30 Days
Time Frame: 26 weeks
Number of hypoglycemic episodes per patient adjusted per 30 days
26 weeks
Nocturnal Hypoglycemic Rate Per 30 Days
Time Frame: 26 weeks
Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
26 weeks
Severe Hypoglycemic Rate Per 30 Days
Time Frame: 26 weeks
Number of severe hypoglycemic episodes per patient adjusted per 30 days
26 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mauricio Silva de Lima, MD, 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.
June 1, 2006

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, 2008

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, 2008

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).
August 2, 2006

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.
August 2, 2006

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.
August 4, 2006

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 7, 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 19, 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-BP-GWBG

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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