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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: exenatide
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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 [ Time Frame: After 24 weeks of randomized treatment ] [ Designated as safety issue: Yes ]

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 [ 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%


Enrollment: 41
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667732

Locations
United States, District of Columbia
Medstar Research Institute
Washington DC, District of Columbia, United States, 20003
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Principal Investigator: Matthew Riddle, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Matthew C. Riddle, Matthew Riddle, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00667732     History of Changes
Other Study ID Numbers: IND 75,235
Study First Received: April 24, 2008
Results First Received: December 11, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
diabetes
insulin
byetta
glucose
blood sugar
metformin
A1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Glargine
Insulin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014