Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy

NCT01488279 | Completed Results

• 1 other identifier: MISP 39681
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that sitagliptin will significantly reduce impairments in insulin secretion and insulin resistance resulting from short-term oral glucocorticoid therapy.

Conditions

Pre-diabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance

Keywords

Pre-diabetes; Impaired fasting glucose; Impaired glucose tolerance; Steroid-induced hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Insulin Sensitivity measured at the end of each treatment period. The primary outcome variable was the difference in the disposition index (DI) determined as the product of the acute insulin response to glucose (AIRg) x the insulin sensitivity index (SI) in subjects during IVGTT on the 8th day (after 7 days) of on dex + placebo, then a after a washout of approximately 4 weeks, participants crossed over to dex + sitagliptin 100 mg x 7 days. Subjects were randomized to order of medication. The primary analyses will be an ANCOVA, including baseline responses as a covariate.

  Measured on day #8 (after 8 days of sitagliptin or placebo) followed by a 4 week washout then measured again on day #8 (after 8 days of crossover treatment).

Secondary Outcomes (4)

• Change in Active GIP

  Active GIP would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GIP

• Change in Active GLP-1

  Active GLP-1 would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GLP-1

• Change in Glucose Response

  measured on day #9 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #9 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT

• Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose)

  measured twice: on day #8 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #8 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT

Study Arms (2)

Dexamethasone 2.5mg and Sitagliptin100mg

ACTIVE COMPARATOR

Participants received Dexamethasone 2.5 mg plus Sitagliptin 100 mg daily for 8 days

Drug: Dexamethasone 2.5 mg and Sitagliptin 100 mg; Drug: Dexamethasone 2.5 mg and placebo tablet

Dexamethasone 2.5mg and placebo tablet

PLACEBO COMPARATOR

Participants received Dexamethasone 2.5 mg plus Sitagliptin-matched placebo tablet daily for 8 days.

Drug: Dexamethasone 2.5 mg and Sitagliptin 100 mg; Drug: Dexamethasone 2.5 mg and placebo tablet

Interventions

Dexamethasone 2.5 mg and Sitagliptin 100 mg DRUG

Participants received Dexamethasone 2.5mg plus Sitaliptin 100mg daily for 8 days

Also known as: Sitagliptin

Dexamethasone 2.5mg and Sitagliptin100mg; Dexamethasone 2.5mg and placebo tablet

Dexamethasone 2.5 mg and placebo tablet DRUG

Participants rececived Dexamethasone 2.5 mg plus placebo tablet daily for 8 days

Also known as: Placebo

Dexamethasone 2.5mg and Sitagliptin100mg; Dexamethasone 2.5mg and placebo tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• impaired fasting glucose
• We will stratify for weight and age.

You may not qualify if:

• Known Type 2 DM
• Severe disease preventing participation in study
• On chronic steroids for any reason
• Already taking DPP-4 inhibitor

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Clinical Research Center

South Burlington, Vermont, 05403, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Dexamethasone; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Sample size or length of study drug may have been too small

Results Point of Contact

• Title: Dr. Annis Marney
• Organization: Frist Clinic Endocrinology

annis.marney@hcahealthcare.com

615-403-8398

Study Officials

• Annis M Marney, MD, MSCI

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Drugs were dispensed by the pharmacy with both the patient and investigator blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Double blind, placebo controlled crossover study

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 12, 2018
• Results First Posted: February 9, 2018

Record last verified: 2018-02

Locations

US (1)