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

Type 2 Diabetes Clinical Trial

— MEXELIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667732
• Other study ID #: IND 75,235
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: February 4, 2013
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2013
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• exenatide
5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
• placebo
5mcg twice a day, increased to 10mcg twice a day for 24 weeks

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Medstar Research Institute	Washington DC	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Amylin Pharmaceuticals, LLC., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		After 24 weeks of randomized treatment	Yes
Secondary	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%	After 24 weeks of randomized treatment	Yes