Trial Outcomes & Findings for Comparison of Insulin Therapy in Treating Post-Transplant Diabetes (NCT NCT01963728)

NCT ID: NCT01963728

Last Updated: 2022-07-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: at 6 months post enrollment
• Results posted on: 2022-07-26

Participant Flow

Medical Clinic

Participant milestones

Measure	Insulin Isophane daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels	Insulin Glargine daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Insulin Isophane daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels	Insulin Glargine daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels
Overall Study Study terminated early	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Insulin Isophane daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels	Insulin Glargine n=1 Participants daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	1 Participants n=1 Participants	1 Participants n=1 Participants
basal insulin types administered	—	1 basal insulin type n=1 Participants	1 basal insulin type n=1 Participants

PRIMARY outcome

Timeframe: at 6 months post enrollment

Population: study terminated early

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 6 months post enrollment

Population: No data study did not complete

measured by continuous glucose monitoring for 5 days

Outcome measures

Outcome data not reported

Adverse Events

Insulin Isophane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Glargine

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

Anne Whitney Brown, MD Principal Investigator

Inova Health Care System

Phone: 703.776.3067

Email: anne.brown@inova.org

Results disclosure agreements

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