Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
GluST1
Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
3 other identifiers
interventional
8
1 country
1
Brief Summary
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D. Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D. Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c \< 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order. Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides. The study will be conducted from august 2014.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 25, 2015
March 1, 2015
4 months
August 29, 2014
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum plasma glucose response
Plasma glucose measured every five minutes after administration
Secondary Outcomes (1)
Duration of hyperglycemic effect of glucagon
Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration
Other Outcomes (13)
Plasma Catecholamine
Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Plasma free fatty acids
Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Plasma Beta-Hydroxybutyric acid
Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
- +10 more other outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORIsotonic Saline
Glucagon 0.1 mg
EXPERIMENTALGlucaGen(r) 0.1 mg administration
Glucagon 0.2 mg
EXPERIMENTALGlucaGen(r) 0.2 mg administration
Glucagon 0.3 mg
EXPERIMENTALGlucaGen(r) 0.3 mg administration
Interventions
Glucagon is given in three different doses according to three research days.
Placebo
Eligibility Criteria
You may qualify if:
- Males and females aged 18-65 years
- Diagnosed with type 1 diabetes \> 3 years
- HbA1c \< 58 mmol/mol
- No appearance of autonome neuropathy
- Body mass index (BMI) between 20-25 kg/m2
- Remained hypoglycemic awareness
- Insulin pump treatment \> 1 year
You may not qualify if:
- Allergic to glucagon or lactose
- Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
- Any disease or condition which would interfere with the subject's safety
- Use of a medication that significantly impacts glucose metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- The Novo Nordic Foundationcollaborator
- University of Copenhagencollaborator
Study Sites (1)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajenthen Ranjan, MD
Hvidovre University Hospital
- STUDY DIRECTOR
Signe Schmidt, MD, PhD
Hvidovre University Hospital
- STUDY CHAIR
Kirsten Nørgaard, MD, DMSc
Hvidovre University Hospital
- STUDY CHAIR
Sten Madsbad, Prof, DMSc
Hvidovre University Hospital
- STUDY CHAIR
Jens J Holst, Prof, DMSc
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
August 29, 2014
First Posted
September 5, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2015
Study Completion
July 1, 2015
Last Updated
March 25, 2015
Record last verified: 2015-03