Trial Outcomes & Findings for Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy (NCT NCT01488279)
NCT ID: NCT01488279
Last Updated: 2018-03-12
Results Overview
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.
COMPLETED
NA
10 participants
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).
2018-03-12
Participant Flow
Participant milestones
| Measure |
Sitagliptin, Then Placebo
Dex 2.5 mg + sitagliptin 100 mg daily (7 days), washout (4-6 weeks), dex + placebo (7 days)
|
Placebo, Then Sitaglipton
Dex 2.5 mg + placebo (7 days), washout (4-6 weeks), Sitalgiptin + placebo ( 7 days)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
Baseline characteristics by cohort
| Measure |
Sitagliptin, Then Placebo
n=5 Participants
This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 week washout, then subjects crossed over to dex + placebo.
|
Placebo, Then Sitagliptin
n=5 Participants
This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days. There was a 4-6 weeks washout, then subjects crossed over to dex + sitagliptin.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 5.5 • n=93 Participants
|
52.5 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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).Population: Subjects were randomized to the order to study medication (dex + sitagliptin vs dex + placebo) by the pharmacy in order to keep double blinding
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.
Outcome measures
| Measure |
Sitagliptin
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
|
Placebo
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days.
|
|---|---|---|
|
Insulin Sensitivity
|
1835.4 ratio without units
Standard Error 340.0
|
1846.0 ratio without units
Standard Error 340.0
|
SECONDARY outcome
Timeframe: 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 GIPPopulation: We did not measure 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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-1Population: We did not measure 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 MTTChange 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).
Outcome measures
| Measure |
Sitagliptin
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
|
Placebo
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days.
|
|---|---|---|
|
Change in Glucose Response
|
4.219 response x 10000 / minute / microUnit/ml
Standard Error 1.368
|
4.228 response x 10000 / minute / microUnit/ml
Standard Error 1.368
|
SECONDARY outcome
Timeframe: 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 MTTWe 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.
Outcome measures
| Measure |
Sitagliptin
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg + sitagliptin 100 mg daily x 7 days followed by MTT and IVGTT on subsequent days.
|
Placebo
n=10 Participants
This arm involves randomization to dexamethasone 2.5 mg orally + placebo x 7 days followed by MTT and IVGTT on subsequent days.
|
|---|---|---|
|
Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose)
|
519.6 pmol/l
Standard Error 0.460
|
558.6 pmol/l
Standard Error 35.3
|
Adverse Events
Sitagliptin, Then Placebo
Placebo, Then Sitagliptin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60