Trial Outcomes & Findings for Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management (NCT NCT02608177)

NCT ID: NCT02608177

Last Updated: 2018-10-12

Results Overview

Time with glucose 70-140 mg/dL

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

last 6 days of each 28-day treatment period

Results posted on

2018-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Linagliptin/Glipizide Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide	Glipizide/Linagliptin Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Linagliptin/Glipizide n=2 Participants Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide	Glipizide/Linagliptin n=1 Participants Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide	Total n=3 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 9.9 • n=5 Participants	70.4 years STANDARD_DEVIATION NA • n=7 Participants	68.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic white race/ethnicity	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: last 6 days of each 28-day treatment period

Time with glucose 70-140 mg/dL

Outcome measures

Outcome measures
Measure	Glipizide n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Glipizide for 4 weeks.	Linagliptin n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Linagliptin for 4 weeks.
Glucose Time in Range	495.2 minutes per day Standard Deviation 671.9	573.3 minutes per day Standard Deviation 669.1

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

SD of glucose readings

Outcome measures

Outcome measures
Measure	Glipizide n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Glipizide for 4 weeks.	Linagliptin n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Linagliptin for 4 weeks.
Glycemic Variability	40.9 mg/dL Standard Deviation 16.1	41.5 mg/dL Standard Deviation 22.7

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Glucose \<70 mg/dL for at least 10 minutes

Outcome measures

Outcome measures
Measure	Glipizide n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Glipizide for 4 weeks.	Linagliptin n=3 Participants Outcome assessed among all participants in both treatment groups at the end of treatment with Linagliptin for 4 weeks.
Hypoglycemia	4 events	2 events

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Population: Labs not run due to small sample size.

Measured by plasma C-reactive protein (CRP)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Population: Labs not run due to small sample size.

Measured by plasma interleukin-6

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Population: Labs not run due to small sample size.

Measured by plasma F2-isoprostanes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Population: Labs not run due to small sample size.

Measured by urine F2-isoprostanes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 6 days of each 28-day treatment period

Population: Labs not run due to small sample size.

Measured by albumin-creatinine ratio

Outcome measures

Outcome data not reported

Adverse Events

Linagliptin/Glipizide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glipizide/Linagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ian de Boer, Associate Director

Kidney Research Institute, University of Washington

Phone: 2067444029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place