Trial Outcomes & Findings for Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation (NCT NCT00936663)

NCT ID: NCT00936663

Last Updated: 2023-09-13

Results Overview

Fasting blood glucose levels at 1 year

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2023-09-13

Participant Flow

recruitment period: 10/2009 to 8/2012 Recruitment location: Transplant Clinic and Nebraska Medicine Hospital

1 subject consented, but dropped out as she was too busy to participate in the study

Participant milestones

Measure	Sitagliptin 100 mg Daily sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented

Baseline characteristics by cohort

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Continuous	55 years STANDARD_DEVIATION 0 • n=1 Participants	34 years STANDARD_DEVIATION 9.9 • n=2 Participants	41 years STANDARD_DEVIATION 14 • n=3 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) White	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Region of Enrollment United States	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
HbA1c	5.6 percentage of glycated haemoglobin STANDARD_DEVIATION 0 • n=1 Participants	5.8 percentage of glycated haemoglobin STANDARD_DEVIATION 1.5 • n=2 Participants	5.7 percentage of glycated haemoglobin STANDARD_DEVIATION 1.0 • n=3 Participants
Fasting Blood Glucose	105 mg/dl STANDARD_DEVIATION 0 • n=1 Participants	125 mg/dl STANDARD_DEVIATION 25.5 • n=2 Participants	118.3 mg/dl STANDARD_DEVIATION 21.3 • n=3 Participants
estimated glomerular filtration rate (eGFR)	48 mL/min/1.73 m² STANDARD_DEVIATION 0 • n=1 Participants	32 mL/min/1.73 m² STANDARD_DEVIATION 9.9 • n=2 Participants	37.3 mL/min/1.73 m² STANDARD_DEVIATION 11.6 • n=3 Participants
Area Under the Curve (AUC) for glucose	—	408 mg*hr/dl STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented	408 mg*hr/dl STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented
AUC for Insulin	—	101.5 mciu*hr/ml STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented	101.5 mciu*hr/ml STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented
AUC Proinsulin	—	52.5 pmol*hr/L STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented	52.5 pmol*hr/L STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented
AUC C peptide	—	26.8 ng*hr/ml STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented	26.8 ng*hr/ml STANDARD_DEVIATION 0 • n=1 Participants • Baseline OGTT was not performed in one patient in Sitagliptin group and one patient in placebo group Reason was not documented

PRIMARY outcome

Timeframe: 1 year

Fasting blood glucose levels at 1 year

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Fasting Blood Glucose	107 mg/dl Standard Deviation 0	102.5 mg/dl Standard Deviation 7.8

SECONDARY outcome

Timeframe: 1 year

HbA1c at 1 year

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
HbA1c	6.1 percentage of glycated haemoglobin Standard Deviation 0	5.8 percentage of glycated haemoglobin Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1 year

estimated glomerular filtration rate (eGFR) at 1 year

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
eGFR	52 mL/min/1.73 m² Standard Deviation 0	41.5 mL/min/1.73 m² Standard Deviation 16.3

SECONDARY outcome

Timeframe: 1 year

Number of episodes of hypoglycemia (blood glucose less than 70 mg/dl)

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Hypoglycemia	0 episodes Standard Deviation 0	0 episodes Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Area Under the Curve for glucose after OGTT

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
AUC for Glucose	277.5 mg*hr/dl Standard Deviation 0	336.5 mg*hr/dl Standard Deviation 101.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Area Under the Curve for insulin after OGTT

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
AUC for Insulin	72.5 mciu*hr/ml Standard Deviation 0	85.75 mciu*hr/ml Standard Deviation 5.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Area Under the Curve for Proinsulin after OGTT

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
AUC for Proinsulin	62.6 pmol*hr/L Standard Error 0	44.83 pmol*hr/L Standard Error 39.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Area Under the Curve for C peptide after OGTT

Outcome measures

Measure	Sitagliptin 100 mg Daily n=1 Participants sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 Participants placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
AUC for C Peptide	19.5 ng*hr/ml Standard Deviation 0	23.28 ng*hr/ml Standard Deviation 16.65

Adverse Events

Sitagliptin 100 mg Daily

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sitagliptin 100 mg Daily n=1 participants at risk sitagliptin 100 mg daily Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.	Placebo n=2 participants at risk placebo Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Cardiac disorders Non-Fatal Myocardial Infarction	100.0% 1/1 • Number of events 1 • 2.5 years	0.00% 0/2 • 2.5 years

Other adverse events

Adverse event data not reported

Additional Information

Vijay Shivaswamy

University of Nebraska Medical Center

Phone: 402-559-6208

Email: vshivaswamy@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place