Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatments glucagon, isotonic saline solution
Phase phase 4
Sponsor Hvidovre University Hospital
Collaborator The Novo Nordic Foundation
Start date September 2014
End date January 2015
Trial size 8 participants
Trial identifier NCT02232971, 2014-002267-15, GluST1_2014, H-1-2014-041

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Placebo Comparator)
Isotonic Saline
isotonic saline solution Natriumklorid isotonisk "SAD"
Placebo
(Experimental)
GlucaGen(r) 0.1 mg administration
glucagon GlucaGen (r)
Glucagon is given in three different doses according to three research days.
(Experimental)
GlucaGen(r) 0.2 mg administration
glucagon GlucaGen (r)
Glucagon is given in three different doses according to three research days.
(Experimental)
GlucaGen(r) 0.3 mg administration
glucagon GlucaGen (r)
Glucagon is given in three different doses according to three research days.

Primary Outcomes

Measure
Maximum plasma glucose response
time frame: Plasma glucose measured every five minutes after administration

Secondary Outcomes

Measure
Duration of hyperglycemic effect of glucagon
time frame: Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
Principal investigator Ajenthen Ranjan, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hvidovre University Hospital.