Trial Outcomes & Findings for Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant (NCT NCT01928199)

NCT ID: NCT01928199

Last Updated: 2022-12-30

Results Overview

Change in 2-hour OGTT-derived blood sugar will be measured at three months and again at six months. These are 3 month OGTT results

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 61 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2022-12-30

Participant Flow

Participant milestones

Measure	Sitagliptin Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Overall Study STARTED	32	29
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Sitagliptin Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	3	5

Baseline Characteristics

Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant

Baseline characteristics by cohort

Measure	Sitagliptin n=32 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=29 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	50.71 years STANDARD_DEVIATION 12.63 • n=5 Participants	51.81 years STANDARD_DEVIATION 16.54 • n=7 Participants	51.34 years STANDARD_DEVIATION 13.01 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Hemoglobin A1c	5.27 percent STANDARD_DEVIATION 0.46 • n=5 Participants	5.13 percent STANDARD_DEVIATION 0.41 • n=7 Participants	5.20 percent STANDARD_DEVIATION 0.44 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Change in 2-hour OGTT-derived blood sugar will be measured at three months and again at six months. These are 3 month OGTT results

Outcome measures

Measure	Sitagliptin n=27 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=23 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
2-hour Oral Glucose Tolerance Test-derived Blood Sugar	141.00 mg/dL Standard Deviation 62.44	165.22 mg/dL Standard Deviation 72.03

SECONDARY outcome

Timeframe: 3 months

Population: Lower numbers for this due to drop out

Number of subjects who have normal 2-hour oral glucose tolerance test-derived blood sugar will be measured at 3 months

Outcome measures

Measure	Sitagliptin n=27 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=23 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Normal 2-hour Oral Glucose Tolerance Test-derived Blood Sugar	16 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 months

We tested another OGTT at 6 months into study, after a 3 month washout from the study drug. Study drug was discontinued after the 3 month OGTT was completed.

Outcome measures

Measure	Sitagliptin n=27 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=23 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
6 Month OGTT Result (Completion of Washout From Study Drug)	174.38 mg/dL Standard Deviation 77.93	171.86 mg/dL Standard Deviation 83.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Measurement of Hemoglobin A1c at 3 months of being on study drug/placebo

Outcome measures

Measure	Sitagliptin n=27 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=23 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Hemoglobin A1c, 3 Month	5.52 percentage of glycosylated hemoglobin Standard Deviation 0.58	5.78 percentage of glycosylated hemoglobin Standard Deviation 0.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

This is the result of hemoglobin A1c measured 3 months after stopping study drug/placebo, tested at the 6 month study time point

Outcome measures

Measure	Sitagliptin n=27 Participants Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=23 Participants Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Hemoglobin A1c, 6 Month	5.91 percentage of glycosylated hemoglobin Standard Deviation 0.84	5.79 percentage of glycosylated hemoglobin Standard Deviation 0.69

Adverse Events

Sitagliptin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sitagliptin n=32 participants at risk Sitaglipitin tablets will be administered orally for 3 months from randomization Initial dose will be 100mg/daily, adjusted per renal function: Creatinine clearance \> or = 50mL/min: 100mg/day Creatinine clearance \> or = 30 and \<50mL/min: 50mg/day Creatinine clearance \<30 mL/min or on dialysis: 25mg/day Sitagliptin	Placebo n=29 participants at risk Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator Placebo
Renal and urinary disorders Urine leak	3.1% 1/32 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	0.00% 0/29 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects
Cardiac disorders Volume overload	3.1% 1/32 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	0.00% 0/29 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects
Musculoskeletal and connective tissue disorders Right arm weakness	3.1% 1/32 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	0.00% 0/29 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects
Surgical and medical procedures Hernia repair	0.00% 0/32 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	3.4% 1/29 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects
Cardiac disorders shortness of breath	0.00% 0/32 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	3.4% 1/29 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects
Renal and urinary disorders Bilateral native nephrectomy	0.00% 0/32 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects	3.4% 1/29 • Number of events 1 • 6 months Adverse events related to admissions described were part of post transplant events, determined not due to medication side effects

Other adverse events

Adverse event data not reported

Additional Information

Rowena Delos Santos

Washington University in St. Louis

Phone: 314-362-8351

Email: delossantos@wustl.edu

Results disclosure agreements

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