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

• ClinicalTrials.gov Identifier: NCT00659711
• Recruitment Status: Unknown
• First Posted: April 16, 2008
• Last Update Posted: December 18, 2012
• Sponsor: Kaleida Health
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Paresh Dandona, MD, Kaleida Health

Tracking Information

• First Submitted Date: April 10, 2008
• First Posted Date: April 16, 2008
• Last Update Posted Date: December 18, 2012
• Study Start Date: March 2008
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 (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 (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: The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• 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

• 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

Recruitment Information

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

Eligibility Criteria

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

• 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: NCT00659711
• Other Study ID Numbers: 1931 Januvia
• 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: Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Paresh Dandona, MD; Kaleida Health

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