Trial Outcomes & Findings for Characteristics of Glargine in Type 2 Diabetics (NCT NCT00574912)

Results Overview

measuring the changes in glucose infusion rate during the 24 hour experimental period.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

24 hours

Results posted on

2017-04-17

Participant Flow

12 individuals will be their own controls completing 5 separate 24 hour protocol studies. If a participant does not complete all protocols, another person will be recruited to complete the protocols until there are 12 completed studies in each arm/group.

Participant milestones

Participant milestones
Measure	1 All Interventions Other: 1--All interventions All participant will be given all 5 interventions in the same order Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,
Overall Study STARTED	20
Overall Study Completed Placebo	12
Overall Study Completed 0.5	12
Overall Study Completed 1.0	12
Overall Study Completed 1.5	12
Overall Study Completed 2.0	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	1 All Interventions Other: 1--All interventions All participant will be given all 5 interventions in the same order Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,
Overall Study Could not place IV lines.	3
Overall Study scheduling conflicts	3
Overall Study Physician Decision	2

Baseline Characteristics

Characteristics of Glargine in Type 2 Diabetics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1--All Interventions n=20 Participants Arm: Other: 1--All interventions All participant will be given all 5 interventions in the same order Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: 12 participants in each arm

measuring the changes in glucose infusion rate during the 24 hour experimental period.