NCT00791076

Brief Summary

The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

November 13, 2008

Results QC Date

May 1, 2017

Last Update Submit

June 29, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Insulin pump therapyType 1 diabeticChronic pancreatitisPancreatic resectionPancreatic polypeptide

Outcome Measures

Primary Outcomes (1)

  • Total Amount of Insulin Administered While on Placebo/PP.

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

    2 years

Secondary Outcomes (1)

  • Frequency of Hypoglycemia Defined as < 60 mg/dl.

    72 hours

Study Arms (2)

Saline Placebo

PLACEBO COMPARATOR

Saline

Drug: Placebo

Pancreatic Polypeptide

ACTIVE COMPARATOR

Pancreatic Polypeptide

Drug: Pancreatic Polypeptide (PP)

Interventions

PlaceboDRUG

2pmol/kg-1/min-1 placebo infused continuously over 72 hours.

Also known as: Saline
Saline Placebo
Pancreatic Polypeptide (PP)DRUG

2pmol/kg-1/min-1 PP infused continuously over 72 hours.

Also known as: PP
Pancreatic Polypeptide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female volunteers between the ages of 18-75 with:
  • subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for \> 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
  • HbA1c levels ≤ 8.5.

You may not qualify if:

  • Lactating or pregnant females.
  • Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
  • Allergy to beef or beef by-products.
  • Hypoglycemia within the past year requiring medical or other assistance to correct.
  • Known autonomic neuropathy.
  • Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
  • Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
  • Not currently on pump therapy.
  • Type 1 DM who has a BMI ≥ 35.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Pancreatitis, Chronic

Interventions

Sodium ChloridePancreatic Polypeptide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Johns Hopkins University Clinical Trials Program
Organization
Johns Hopkins University School of Medicine
registerclinicaltrials@jhmi.edu
410-550-6484

Study Officials

  • Dariush Elahi, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Locations

US(1)