Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes

Phase 4

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Isotonic saline solution; Drug: Glucagon

• Registration Number: NCT02232971
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Isotonic saline solution	Isotonic Saline
Glucagon 0.1 mg	Glucagon	GlucaGen(r) 0.1 mg administration
Glucagon 0.2 mg	Glucagon	GlucaGen(r) 0.2 mg administration
Glucagon 0.3 mg	Glucagon	GlucaGen(r) 0.3 mg administration

Primary Outcome Measures

Name	Time	Method
Maximum plasma glucose response	Plasma glucose measured every five minutes after administration

Secondary Outcome Measures

Name	Time	Method
Duration of hyperglycemic effect of glucagon	Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark