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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


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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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