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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver

NCTNCT01986231 (opens ClinicalTrials.gov in a new tab)Other idIRB00006947
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
12 participants (actual)
Sponsor
Legacy Health System · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2011
Primary completion
Dec 2012
Completion
Dec 2012
First posted
18 Nov 2013 (estimated)
Last update posted
4 May 2015 (estimated)
Conditions
Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. N/A

    Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver

    NCT01986231

    Jan 2011 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to learn if giving multiple doses of a hormone called glucagon can cause a major decrease in liver glycogen (animal starch). Glucagon is currently approved by the Food and Drug Administration to be given as a large dose to treat severe low blood sugar. Our group is studying whether glucagon can be given in repeated small doses to prevent hypoglycemia.

Interventions

  • GlucagonDrug

Arms1

  • Experimental

    Open-Label Glucagon

    Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration

    Time frame · Baseline and 41 hours

    Registry description

    The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.

Secondary outcomes(1)

  1. Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration

    Time frame · Baseline and 41 hours

    Registry description

    The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fed state.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 41 hours

Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration

GroupValue (g/L)Spread
Open-Label Glucagon6.54.5
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline and 41 hours

Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration

GroupValue (g/L)Spread
Open-Label Glucagon10.67.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Open-Label GlucagonSubjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35. Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.–0 / 123 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2015

Effect of Repeated Glucagon Doses on Hepatic Glycogen in Type 1 Diabetes: Implications for a Bihormonal Closed-Loop System.

Castle et al. 2015Diabetes carecited by 29

PMID 26341131PMC4613914DOI 10.2337/dc15-0754PUB-26341131

Rights unknown
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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 1 diabetes mellitus diagnosed for at least 6 months * Current usage of subcutaneous insulin pump treatment * Age 18-65 years * HbA1c of 5.5 - 7.7% at screening visit * BMI 18-35 kg/m2 * Willingness to follow all study procedures, including attending all clinic visits * Willingness to sign informed consent and HIPAA documents Exclusion Criteria: * Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test. * Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). * Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2. * Hematocrit of less than or equal to 34%. * Congestive heart failure, NYHA class II, III or IV. * Coronary artery or cerebrovascular disease. * Active foot ulceration. * Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator). * Active malignancy, except basal cell or squamous cell skin cancers. * Major surgical operation within 30 days prior to screening. * Seizure disorder (epilepsy). * Contraindication to an MRI scan, including having metallic splinters in the eye, a cardiac pacemaker, defibrillator, or any other ferromagnetic or electronically charged implanted device, or ferromagnetic clip(s) in the central nervous system. * Currently administration of oral or parenteral corticosteroids. * Use of an investigational drug within 30 days prior to screening. * Bleeding disorder, treatment with warfarin, or platelet count below 50,000. * History weight loss of ≥ 5 lbs over the prior month. * Weight ≥ 300 lbs. * Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. * Any reason the principal investigator deems exclusionary.

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