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The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects (1928)

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ClinicalTrials.gov Identifier: NCT00659711
Recruitment Status : Unknown
Verified December 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was:  Active, not recruiting
First Posted : April 16, 2008
Last Update Posted : December 18, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health

Tracking Information
First Submitted Date  ICMJE April 10, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases reactive oxygen species (ROS) generation by MNC, protein and mRNA expression of p47phox subunit of NADPH oxidase, in MNC's of obese type 2 diabetic patients [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases reactive oxygen species (ROS) generation by MNC, protein and mRNA expression of p47phox subunit of NADPH oxidase, in MNC's of obese type 2 diabetic patients [ Time Frame: End of the study ]
Change History Complete list of historical versions of study NCT00659711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
oxidative stress [ Time Frame: 12 weeks ]
To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients [ Time Frame: end of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
Official Title  ICMJE The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
Brief Summary

Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.

Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Januvia (Sitagliptin) 100 mg
    The first group will be started on 100 mg sitagliptin daily for 12 weeks
    Other Name: januvia
  • Drug: Placebo
    will be placed on a placebo for 12 weeks.
Study Arms  ICMJE
  • Active Comparator: Januvia 100mg
    The first group will be started on 100 mg sitagliptin daily for 12 weeks
    Intervention: Drug: Januvia (Sitagliptin) 100 mg
  • Placebo Comparator: placebo
    will be placed on a placebo for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females with age 20-75 years inclusive.
  • Type 2 diabetes
  • Males and Females BMI > 30
  • Subjects on statins, ACE inhibitors, thiazolidenediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.
  • BP under control -No change required to BP medications
  • HbA1c > 7%

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),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
  • Subjects on Exenatide, incretin or insulin therapy
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 NCT00659711
Other Study ID Numbers  ICMJE 1931 Januvia
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 Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Paresh Dandona, MD Kaleida Health
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