Trial · NCT01488279
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
NCT01488279, Not applicable, Completed, University of Vermont; results first posted 2018-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy. Trials, record NCT01488279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
- NCT number
- NCT01488279
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Vermont
- Conditions
- Pre-diabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
- Interventions
- Dexamethasone 2.5 mg and Sitagliptin 100 mg, Dexamethasone 2.5 mg and placebo tablet
- First posted
- 2011-12-08
- Last updated
- 2018-03-12
- Results first posted
- 2018-02-09
- Limitations and caveats
- Sample size or length of study drug may have been too small
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Sensitivity | 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). | 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. |
| Secondary | 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 | We had planned to measure the difference or change in active GIP in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. However, when other measures were negative, we opted not to pursue this lab assay for cost and time. We did not perform measures of GIP. |
| Secondary | 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 | As with GIP, we had planned to measure the difference or change in active GLP-1 in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. We had hypothesized that GIP and GLP-1 would be elevated while on the DPP4 inhibitor compared to placebo as this is the mechanism of action of the drug sitagliptin. When other measures were negative, we elected not to pursue this due to time and cost. |
| Secondary | 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 glucose response during the MTT. This was the Si (insulin sensitivity). We sought to determine whether there was an improvement in the glucose response after a meal on the DPP4i compared to placebo in the face of steroid (dexamethasone). |
| Secondary | 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 | We measured the change in insulin secretion (AIRg or acute insulinogenic response to glucose) during the MTT and compared the insulin secretion on the DPP4 inhibitor (sitagliptin) compared to placebo. We had expected the AIRg to be greater with DPP4i compared to placebo. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin Sensitivity | 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). | Subjects were randomized to the order to study medication (dex + sitagliptin vs dex + placebo) by the pharmacy in order to keep double blinding | ratio without units | MEAN |
| SECONDARY | 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 | We did not measure GIP | ||
| SECONDARY | 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 | We did not measure GLP-1 | ||
| SECONDARY | 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 | response x 10000 / minute / microUnit/ml | LEAST_SQUARES_MEAN | |
| SECONDARY | 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 | pmol/l | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin Sensitivity | Sitagliptin | 1835.4 | Standard Error 340.0 | ratio without units | |
| Insulin Sensitivity | Placebo | 1846.0 | Standard Error 340.0 | ratio without units | |
| Change in Glucose Response | Sitagliptin | 4.219 | Standard Error 1.368 | response x 10000 / minute / microUnit/ml | |
| Change in Glucose Response | Placebo | 4.228 | Standard Error 1.368 | response x 10000 / minute / microUnit/ml | |
| Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose) | Sitagliptin | 519.6 | Standard Error 0.460 | pmol/l | |
| Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose) | Placebo | 558.6 | Standard Error 35.3 | pmol/l |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin, Then Placebo | 5 | |
| Overall Study | STARTED | Placebo, Then Sitaglipton | 5 | |
| Overall Study | COMPLETED | Sitagliptin, Then Placebo | 5 | |
| Overall Study | COMPLETED | Placebo, Then Sitaglipton | 5 | |
| Overall Study | NOT COMPLETED | Sitagliptin, Then Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo, Then Sitaglipton | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin, Then Placebo | ||
| Total, all-cause mortality | Placebo, Then Sitagliptin | ||
| Total, other adverse events | Sitagliptin, Then Placebo | 0 | 5 |
| Total, other adverse events | Placebo, Then Sitagliptin | 0 | 5 |
| Total, serious adverse events | Sitagliptin, Then Placebo | 0 | 5 |
| Total, serious adverse events | Placebo, Then Sitagliptin | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitagliptin, Then Placebo vs Placebo, Then Sitagliptin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01488279
GET https://conductscience.org/api/trials/v1/NCT01488279/registered