Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: Glucagon (Drug); Isotonic saline solution (Other)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s): Ajenthen Ranjan, MD, Principal Investigator, Affiliation: Hvidovre University Hospital Signe Schmidt, MD, PhD, Study Director, Affiliation: Hvidovre University Hospital Kirsten Nørgaard, MD, DMSc, Study Chair, Affiliation: Hvidovre University Hospital Sten Madsbad, Prof, DMSc, Study Chair, Affiliation: Hvidovre University Hospital Jens J Holst, Prof, DMSc, Study Chair, Affiliation: University of Copenhagen
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.
Clinical Details
Official title: Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Primary outcome: Maximum plasma glucose response
Secondary outcome: Duration of hyperglycemic effect of glucagon
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Hvidovre University Hospital, Hvidovre 2650, Denmark
Additional Information
DiaCon group focuses on developing new technologies for treatment of type 1 diabetes
Starting date: September 2014
Last updated: March 24, 2015
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