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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT00659711
First received: April 10, 2008
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Drug: Januvia (Sitagliptin) 100 mg
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: januvia
Placebo Comparator: placebo
will be placed on a placebo for 12 weeks.
 Drug: Placebo
will be placed on a placebo for 12 weeks.
Other Name: placebo

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659711

Locations
United States, New York
115 Flint Road
Buffalo, New York, United States, 14221
Sponsors and Collaborators
Kaleida Health
Merck
Investigators
Principal Investigator: Paresh Dandona, MD Kaleida Health
  More Information

No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT00659711     History of Changes
Other Study ID Numbers: 1931 Januvia
Study First Received: April 10, 2008
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013