Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

NCT02015910 | Terminated Phase 4 Results DMC

• 1 other identifier: MISP-RC50959
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent Wounds Healed

  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.

  12 weeks

Study Arms (2)

Januvia (Sitagliptin)

EXPERIMENTAL

Sitagliptin 100 mg a day for 12 weeks

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sitagliptin DRUG

Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator

Also known as: Januvia

Januvia (Sitagliptin)

Placebo DRUG

Sugar pill manufactured to mimick Sitagliptin 100mg pill.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Georgetown University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, 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

Limitations and Caveats

Data was collected for one subject but could not be analyzed due to insufficient enrollment.

Results Point of Contact

• Title: Paul J. Kim, DPM, Director of Research
• Organization: Georgetown University Medical Center

Paul.J.Kim@gunet.georgetown.edu

202-444-3059

Study Officials

• Paul J Kim, DPM

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Podiatric Medicine

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 6, 2017
• Results First Posted: January 6, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)