Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
This study has been terminated.
(Terminated by the sponsor due to slow enrollment)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University
First received: December 13, 2013
Last updated: May 1, 2015
Last verified: May 2015
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.
Type II Diabetes
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Experimental: Januvia (Sitagliptin)
Sitagliptin 100 mg a day for 12 weeks
Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
Other Name: Januvia
Placebo Comparator: Placebo
Sugar pill manufactured to mimick Sitagliptin 100mg pill.
|Ages Eligible for Study:
||18 Years to 80 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
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
|Medstar Georgetown University Hospital
|Washington, District of Columbia, United States, 20007 |
Merck Sharp & Dohme Corp.
||Paul J Kim, DPM
||Paul J. Kim, DPM, Doctor of Podiatric Medicine, Georgetown University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 13, 2013
||May 1, 2015
||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:
ClinicalTrials.gov processed this record on August 30, 2016
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action