Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments januvia (sitagliptin) 100 mg, placebo
Sponsor Kaleida Health
Collaborator Merck Sharp & Dohme Corp.
Start date March 2008
End date December 2013
Trial size 40 participants
Trial identifier NCT00659711, 1931 Januvia

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
The first group will be started on 100 mg sitagliptin daily for 12 weeks
januvia (sitagliptin) 100 mg januvia
The first group will be started on 100 mg sitagliptin daily for 12 weeks
(Placebo Comparator)
will be placed on a placebo for 12 weeks.
placebo placebo
will be placed on a placebo for 12 weeks.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
oxidative stress
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
Principal investigator Paresh Dandona, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Kaleida Health.