Trial Outcomes & Findings for The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients (NCT NCT00798590)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	GLP-1 Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.	Saline Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Overall Study STARTED	11	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	GLP-1 Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.	Saline Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Overall Study P.I, Left institution. Study terminated	11	8

Baseline Characteristics

The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLP-1 n=11 Participants Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.	Saline n=8 Participants Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.	Total n=19 Participants Total of all reporting groups
Age, Customized >=21 and <=75	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.

Outcome measures

Outcome data not reported

Adverse Events

GLP-1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

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