Trial Outcomes & Findings for Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes (NCT NCT00869414)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-06-29

Participant Flow

This study was prematurely terminated because the P.I. is deceased. Although 16 participants were enrolled, however, the number of participants starting and completing the study as well as the number of participants assigned to each Arm/Group are unknown, since no data are available

Participant milestones

Participant milestones
Measure	Insulin Glargine Only in Morning Morning only administration of insulin glargine Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night.	Insulin Glargine Only at Evening Evening only administration of insulin glargine Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning.	Split Dose Insulin Glargine Split dose administration of insulin glargine, half dose in morning, half dose in evening split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening
Overall Study STARTED	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=16 Participants Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening).
Age, Customized Age, > 18 years old	16 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 weeks

Population: This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available

Outcome measures

Outcome data not reported

Adverse Events

Insulin Glargine Only in Morning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Glargine Only at Evening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Split Dose 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

Johns Hopkins University Clinical Trials Program

Johns Hopkins University School of Medicine

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place