Trial Outcomes & Findings for The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients (NCT NCT00791076)

Results Overview

Glucose values and the pattern of glycemic excursions over the 72 hour test period.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Saline Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours. OR Pancreatic Polypeptide Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Saline Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours. OR Pancreatic Polypeptide Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.
Overall Study Study was terminated,PI left institution	8

Baseline Characteristics

The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=8 Participants 2pmol/kg-1/min-1 saline infused continuously over 72 hours OR 2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Age, Customized >=18 and <=75	8 participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.

Glucose values and the pattern of glycemic excursions over the 72 hour test period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

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

Outcome measures

Outcome data not reported

Adverse Events

Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pancreatic Polypeptide

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