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

NCT00667732 | Completed Phase 4 Results DMC

• 1 other identifier: IND 75,235
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; insulin; byetta; glucose; blood sugar; metformin; A1c

Outcome Measures

Primary Outcomes (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

  After 24 weeks of randomized treatment

Secondary Outcomes (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

  After 24 weeks of randomized treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive exenatide as part of their diabetes treatment

Drug: exenatide

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

exenatide DRUG

5mcg twice a day, increasing to 10mcg twice a day for 24 weeks

Also known as: Byetta

1

placebo DRUG

5mcg twice a day, increased to 10mcg twice a day for 24 weeks

2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Amylin Pharmaceuticals, LLC.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (3)

Medstar Research Institute

Washington D.C., District of Columbia, 20003, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Matthew Riddle
• Organization: Oregon Health and Science University

riddlem@ohsu.edu

503-494-0557

Study Officials

• Matthew Riddle, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matthew Riddle, MD

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 6, 2013
• Results First Posted: February 6, 2013

Record last verified: 2013-02

Locations

US (3)