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

NCT00659711 | Completed Results

• 1 other identifier: 1931 Januvia
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in 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

  12 weeks

Secondary Outcomes (1)

• Change in Oxidative Stress From Baseline to 12 Weeks

  value at 12 weeks minus value at baseline

Study Arms (2)

Januvia 100mg

ACTIVE COMPARATOR

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

Drug: Januvia (Sitagliptin) 100 mg

placebo

PLACEBO COMPARATOR

will be placed on a placebo for 12 weeks.

Drug: Placebo

Interventions

Januvia (Sitagliptin) 100 mg DRUG

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

Also known as: januvia

Januvia 100mg

Placebo DRUG

will be placed on a placebo for 12 weeks.

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

115 Flint Road

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

7165351850

Study Officials

• Paresh Dandona, MD

  Kaleida Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 21, 2022
• Results First Posted: July 21, 2022

Record last verified: 2022-06

Locations

US (1)