Phase 2 N=24 Randomized Single-blind Treatment

Exeantide in Type 2 Diabetes on Insulin

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01154933 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Fasting Insulin — 12.7; 13.1; 16.4; 13.9 μU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: exenatide 5 mcg (Drug); exenatide 10 mcg (Drug); placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University at Buffalo
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Insulin	12.7; 13.1; 16.4; 13.9	—
SECONDARY Weight	0; 3	—
SECONDARY HbA1c	-1.2; -0.5	—
SECONDARY Intranuclear NFκB Binding Activity	26; 0	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01154933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.