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

This study has been completed.
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Matthew C. Riddle, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00667732
First received: April 24, 2008
Last updated: February 4, 2013
Last verified: February 2013

April 24, 2008
February 4, 2013
March 2007
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The hemoglobin A1c test, which measures the blood glucose level over a 2-month period, will be looking at glucose control. [ Time Frame: Weeks 8, 32 and 58 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00667732 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%
Participants' changes in weight will also be closely examined, since one of the primary objectives of this study was to look at the effect of this regimen of drugs to control blood sugar levels as well as weight. [ Time Frame: Weeks 8, 32 and 58 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: exenatide
    5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
    Other Name: Byetta
  • Drug: placebo
    5mcg twice a day, increased to 10mcg twice a day for 24 weeks
  • Active Comparator: 1
    Participants will receive exenatide as part of their diabetes treatment
    Intervention: Drug: exenatide
  • Placebo Comparator: 2
    Participants will receive placebo rather than exenatide as part of their diabetes treatment
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
April 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667732
IND 75,235
Yes
Matthew C. Riddle, Oregon Health and Science University
Oregon Health and Science University
  • Amylin Pharmaceuticals, LLC.
  • Eli Lilly and Company
Principal Investigator: Matthew Riddle, MD Oregon Health and Science University
Oregon Health and Science University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP