How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics (MEXELIN)

February 4, 2013 updated by: Matthew C. Riddle, Oregon Health and Science University

Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.

There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

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

  • United States
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20003
        • Medstar Research Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients with type 2 diabetes
  • Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for > 3 months
  • Age range 30 to 70 years
  • Body mass index 25-45 kg/m2
  • HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)
  • Less than 50% of randomized participants will have used insulin previously

Exclusion Criteria:

  • Use of more than two antihyperglycemic agents within the last 3 months
  • Use of more than one daily injection of any kind of insulin in the last 3 months
  • Positive anti-GAD antibody (test required in screening)
  • Fasting C-peptide <0.5 ng/mL (test required in screening)
  • Pregnancy (test required in screening if able to conceive) or lactation
  • Excessive use of alcohol or evidence of other form of drug dependency
  • Unwillingness or inability to grant informed consent
  • Unwillingness or inability to perform self-monitoring of blood glucose
  • Unwillingness or inability to inject insulin and/or inject exenatide
  • Serum creatinine >1.3 mg/dL in women or 1.4 in men
  • Retinopathy which has required photocoagulation for treatment
  • Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol
  • Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control
  • Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying
  • Use prednisone or other systemic glucocorticoid drug in the last 3 months
  • Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months
  • Use of any unproven investigational drug within the last 3 months

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Participants will receive exenatide as part of their diabetes treatment
Drug: exenatide
5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
Other Names:
  • Byetta
Placebo Comparator: 2
Participants will receive placebo rather than exenatide as part of their diabetes treatment
Drug: placebo
5mcg twice a day, increased to 10mcg twice a day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time Frame: After 24 weeks of randomized treatment
After 24 weeks of randomized treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time Frame: After 24 weeks of randomized treatment
efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%
After 24 weeks of randomized treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Eli Lilly and Company
Amylin Pharmaceuticals, LLC.

Investigators

  • Principal Investigator: Matthew Riddle, MD, Oregon Health and Science University

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, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 75,235

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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