Exeantide in Type 2 Diabetes on Insulin

Tracking Information
First Submitted Date ICMJE	June 30, 2010
First Posted Date ICMJE	July 1, 2010
Last Update Posted Date	December 17, 2012
Study Start Date ICMJE	April 2008
Actual Primary Completion Date	November 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 30, 2010)	insulin dose [ Time Frame: 12 weeks ]; To compare the total insulin dose 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01154933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 30, 2010)	weight [ Time Frame: 12 weeks ]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: 12 weeks ]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.; inflammation [ Time Frame: 12 weeks ]To investigate the hypothesis that a single dose of exenatide subcutaneously (5 mcg/injection) decreases the intranuclear NFκB binding activity and decreases the transcription of pro-inflammatory genes regulated by NFκB in MNC's of insulin treated type 2 diabetic patients as compared to placebo.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Exeantide in Type 2 Diabetes on Insulin
Official Title ICMJE	The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin
Brief 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes
Intervention ICMJE	Drug: exenatide 5 mcg exenatide 5 mcg; Drug: exenatide 10 mcg exenatide 10 mcg; Drug: placebo saline sq
Study Arms	Experimental: exenatide 5 mcg exenatide 5 mcg Intervention: Drug: exenatide 5 mcg; Experimental: exenatide 10 mcg exenatide 10 mcg Intervention: Drug: exenatide 10 mcg; Placebo Comparator: placebo placebo Intervention: Drug: placebo
Publications *	Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2‒Keap-1‒Regulated Antioxidant Enzymes: Relevance to β-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 30, 2010)	63
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2011
Actual Primary Completion Date	November 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01154933
Other Study ID Numbers ICMJE	1930
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Paresh Dandona, MD, Kaleida Health
Study Sponsor ICMJE	Kaleida Health
Collaborators ICMJE	Amylin Pharmaceuticals, LLC.
Investigators ICMJE	Principal Investigator: Paresh Dandona, MBBS SUNY at Buffalo
PRS Account	Kaleida Health
Verification Date	December 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP