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

NCT ID: NCT00659711

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Januvia 100mg

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

Group Type: ACTIVE_COMPARATOR

Januvia (Sitagliptin) 100 mg

Intervention Type: DRUG

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

placebo

will be placed on a placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

will be placed on a placebo for 12 weeks.

Interventions

Januvia (Sitagliptin) 100 mg

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

Intervention Type: DRUG

Placebo

will be placed on a placebo for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

januvia

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Paresh Dandona

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paresh Dandona, MD

Role: PRINCIPAL_INVESTIGATOR

Kaleida Health

Locations

115 Flint Road

Buffalo, New York, United States

Countries

United States

Other Identifiers

1931 Januvia

Identifier Type: -

Identifier Source: org_study_id