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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name MEXELIN

Overview

Status
Completed
Phase
Phase 4
Enrollment
41 participants (actual)
Sponsor
Oregon Health and Science University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Mar 2007
Primary completion
Oct 2009
Completion
Apr 2010
First posted
28 Apr 2008 (estimated)
Last update posted
6 Feb 2013 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 4

    MEXELIN

    NCT00667732

    Mar 2007 to Apr 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • placeboDrug

Arms2

  • Active comparator

    1

    Participants will receive exenatide as part of their diabetes treatment

  • Placebo comparator

    2

    Participants will receive placebo rather than exenatide as part of their diabetes treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(1)
  1. 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

    Registry description

    efficacy criteria, 50% of per protocol participants reached A1c target of \<6.5%

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· After 24 weeks of randomized treatment

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

GroupValue (percentage of participants)
Exenatide Group47
Placebo Group12
Secondary and other outcome results(1)
Secondary outcomeNumber· After 24 weeks of randomized treatment

The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment

GroupValue (percentage of participants)Spread
Exenatide Group500.27
Placebo Group12–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Run-In GroupAll participants took exenatide twice daily in addition to their Metformin dose.–0 / 3821 / 38
Exenatide Randomization GroupAfter run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels–0 / 1715 / 17
Placebo Randomization PeriodAfter run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels–0 / 1710 / 17
Exenatide Open-Label (Previous Exenatide)Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level–0 / 1411 / 14
Exenatide Open-Label (Previous Placebo)Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level–0 / 1712 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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