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Exeantide in Type 2 Diabetes on Insulin

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

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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