Trial Outcomes & Findings for Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital (NCT NCT01203774)

Results Overview

Data was collected by group

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)

Results posted on

2021-08-06

Participant Flow

Although this is a crossover study, no information is available on the participants that completed phase 1 and started phase 2, and so these milestones are not included. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. The number of participants started and completed reflects the participants confirmed to have started and completed the study. 43 participants were consented.

Participant milestones

Participant milestones
Measure	Syringe-administered Then Pen-administered Glargine Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day	Pen-administered, Then Syringe-admnistered Glargine SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day
Overall Study STARTED	10	21
Overall Study COMPLETED	10	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=43 Participants Pen-administered, then syringe-admnistered Glargine Group (1) AND Syringe-administered then pen-administered Glargine Group (2) Group 1: SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day Group 2: Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day
Age, Customized Age 22-70	43 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)

Population: The only outcome measure available for this measurement is "by group". This measure cannot be entered "by intervention" (e.g. Arm 1: "Pen", Arm 2: "Syringe"). Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. Participants that did not complete the study are not included.

Data was collected by group

Outcome measures

Outcome measures
Measure	Group 1: Pen-administered, Then Syringe-admnistered Glargine n=21 Participants SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day	Group 2: Syringe-administered Then Pen-administered Glargine n=10 Participants Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day
HbA1c at Three Months of Each Period of Treatment Baseline HbA1c	10.7 percentage (DCCT unit) Standard Deviation 2.2	11.2 percentage (DCCT unit) Standard Deviation 2.5
HbA1c at Three Months of Each Period of Treatment HbA1C at 3 months (end of intervention 1, before crossover)	7.8 percentage (DCCT unit) Standard Deviation 1.7	7.3 percentage (DCCT unit) Standard Deviation 1.4
HbA1c at Three Months of Each Period of Treatment HbA1c at 6 Months (end of dose 2, after crossover)	8.5 percentage (DCCT unit) Standard Deviation 2.0	7.1 percentage (DCCT unit) Standard Deviation 1.6

SECONDARY outcome

Timeframe: 6 months of treatment after discharge from the hospital

Population: No data is available for this outcome measure. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study.

Outcome measures

Outcome data not reported

Adverse Events

Pen-administered Glargine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Syringe-administered 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

Director, Clinical Research Administration

University of Colorado Denver

Phone: 3037241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place