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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Januvia (Sitagliptin) 100 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14221
      • 115 Flint Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Januvia 100mg; The first group will be started on 100 mg sitagliptin daily for 12 weeks	Drug: Januvia (Sitagliptin) 100 mg; The first group will be started on 100 mg sitagliptin daily for 12 weeks; Other Names: januvia
PLACEBO_COMPARATOR: placebo; will be placed on a placebo for 12 weeks.	Drug: Placebo; will be placed on a placebo for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oxidative Stress From Baseline to 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 Outcome measures given are calculated from the baseline - 12 weeks.	value at 12 weeks minus value at baseline

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (ESTIMATE): April 16, 2008

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 1931 Januvia