Exeantide in Type 2 Diabetes on Insulin

• ClinicalTrials.gov Identifier: NCT01154933
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: December 17, 2012
• Sponsor: Kaleida Health
• Collaborator: Amylin Pharmaceuticals, LLC.
• Information provided by (Responsible Party): Paresh Dandona, MD, Kaleida Health

Tracking Information

• First Submitted Date: June 30, 2010
• First Posted Date: July 1, 2010
• Last Update Posted Date: December 17, 2012
• Study Start Date: April 2008
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exeantide in Type 2 Diabetes on Insulin
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 30, 2010): 63
• Original Estimated Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01154933
• Other Study ID Numbers: 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: Kaleida Health
• Collaborators: Amylin Pharmaceuticals, LLC.

Investigators

• Principal Investigator: Paresh Dandona, MBBS; SUNY at Buffalo

• PRS Account: Kaleida Health
• Verification Date: December 2012