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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)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

exenatide

placebo

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

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Arm Type

Active Comparator

Arm Description

Participants will receive exenatide as part of their diabetes treatment

Arm Title

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

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

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

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