DRUG
exenatide 5 mcg
exenatide 5 mcg
Exeantide in Type 2 Diabetes on Insulin
Status
Completed
Phase
Phase 2
Enrollment
24
Locations
1
Results
Posted
Publications
1
Study summary
What the protocol is testing.
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss. The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.
Interventions
Treatment arms and agents.
DRUG
exenatide 10 mcg
exenatide 10 mcg
DRUG
placebo
saline sq
Timeline
From registration to results.
First posted
Jul 1, 2010
Study start
Apr 2008
Primary completion
Nov 2011
Study completion
Nov 2011
Results posted
Oct 6, 2022
Registry updated
Oct 6, 2022
Outcomes
What the study measures.
Primary outcomes
Fasting Insulin
Time frame · after 24 hours fast at baseline and 12 weeks
To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
Secondary outcomes
Weight
Time frame · value at 12 weeks minus value at baseline
To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients
HbA1c
Time frame · value at 12 weeks minus value at baseline
To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
Intranuclear NFκB Binding Activity
Time frame · measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Males or females 20-75 years of age inclusive. * Type 2 diabetes * On insulin therapy * HbA1c ≥7.5% and ≤ 9% * BMI ≥ 30 kg/m2 * Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Exclusion Criteria: * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks * Pregnancy * Hepatic disease (abnormal LFT's) * Use of DPP4 inhibitors. * Renal impairment (serum creatinine \> 1.5) * Participation in any other concurrent clinical trial * Any other life-threatening, non-cardiac disease * Uncontrolled hypertension (BP \> 160/100 mm of Hg) * Congestive Heart Failure. * Use of an investigational agent or therapeutic regimen within 30 days of study
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Millard Fillmore Gates Hospital
Buffalo, New York, United States
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More studies on Exenatide.
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Active, not recruiting
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Phase 3
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2026-05
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Related PeptideStat pages
Put the record in context.
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