How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics (MEXELIN)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
exenatide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, insulin, byetta, glucose, blood sugar, metformin, A1c
Eligibility Criteria
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
Sites / Locations
- Medstar Research Institute
- Mayo Clinic
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Participants will receive exenatide as part of their diabetes treatment
Participants will receive placebo rather than exenatide as part of their diabetes treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%
Full Information
NCT ID
NCT00667732
First Posted
April 24, 2008
Last Updated
February 4, 2013
Sponsor
Oregon Health and Science University
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00667732
Brief Title
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Acronym
MEXELIN
Official Title
Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, insulin, byetta, glucose, blood sugar, metformin, A1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive exenatide as part of their diabetes treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo rather than exenatide as part of their diabetes treatment
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
5mcg twice a day, increased to 10mcg twice a day for 24 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Description
efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%
Time Frame
After 24 weeks of randomized treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Riddle, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Research Institute
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
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