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

University at Buffalo

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Januvia (Sitagliptin) 100 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00659711

1931 Januvia

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Januvia 100mg

Active Comparator group

Description:

The first group will be started on 100 mg sitagliptin daily for 12 weeks

Treatment:

Drug: Januvia (Sitagliptin) 100 mg

placebo

Placebo Comparator group

Description:

will be placed on a placebo for 12 weeks.

Treatment:

Drug: Placebo