Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Georgetown University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University
ClinicalTrials.gov Identifier:
NCT02015910
First received: December 13, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The primary objective of this study is to compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.

The hypothesis for this study is that subjects receiving daily doses of sitagliptin in combination with their regular antihyperglycemic medications will result in increased healing rates as well as a greater number of healed wounds as compared to subjects receiving placebo and their regular antihyperglycemic medications.


Condition Intervention Phase
Insulin Dependent Diabetes Mellitus (Type II Diabetes)
Drug: Sitagliptin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Percent Wounds Healed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.


Estimated Enrollment: 250
Study Start Date: January 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Januvia (Sitagliptin)
Sitagliptin 100 mg a day for 12 weeks
Drug: Sitagliptin
Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
Other Name: Januvia
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Sugar pill manufactured to mimick Sitagliptin 100mg pill.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age >18
  • Type II Diabetes with glycated hemoglobin (hemoglobin A1C) of < 11
  • Currently on an oral hyperglycemic medication other than sitagliptin
  • A chronic wound defined as the lack of wound healing progress of <15% per week or 50% over a month period
  • Ankle brachial index of > 0.80
  • Wound located on the foot or ankle (Wagner Grade 1,2)
  • Able to comply with the requirements of the research trial

Exclusion Criteria:

  • Current use of dipeptidyl-peptidase four (DPP-4) inhibitor or glucagon like peptide one (GLP-1)agonist
  • End stage renal disease
  • Currently enrolled in another research trial that involves treatment of the wound
  • Active infection of the wound
  • Wound that probes to bone with osteomyelitis (Wagner Grade 3)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015910

Contacts
Contact: Paul J Kim, DPM 202-444-3059

Locations
United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Paul Kim, DPM    202-444-3059      
Principal Investigator: Paul Kim, DPM         
Sponsors and Collaborators
Georgetown University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Paul J Kim, DPM Georgetown University
  More Information

No publications provided

Responsible Party: Paul J. Kim, DPM, Doctor of Podiatric Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT02015910     History of Changes
Other Study ID Numbers: MISP-RC50959
Study First Received: December 13, 2013
Last Updated: April 7, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Foot Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Foot Ulcer
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Neuropathies
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014