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

Diabetes Mellitus, Type 1 Clinical Trial

— GluST1  

Official title:

Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02232971
• Other study ID #: GluST1_2014
• Secondary ID: 2014-002267-15H-
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 29, 2014
• Last updated: March 24, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Glucagon
Glucagon is given in three different doses according to three research days.

Other:
• Isotonic saline solution
Placebo

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	The Novo Nordic Foundation, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Catecholamine		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Plasma free fatty acids		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Plasma Beta-Hydroxybutyric acid		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Plasma Glucagon		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Serum Growth hormone		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Serum Cortisol		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Serum Insulin (Novorapid)		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Other	Adverse reaction: Stomach pain	Visual analog scale	One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.	Yes
Other	Adverse reaction: Headache	Visual Analog scale	One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.	Yes
Other	Adverse Reaction: Vertigo	Visual analog scale	One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.	Yes
Other	Adverse reaction: Nausea	Visual analog scale	One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.	Yes
Other	Adverse reaction: Hunger	Visual analog scale	One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.	Yes
Other	Plasma triglycerides		Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration	No
Primary	Maximum plasma glucose response		Plasma glucose measured every five minutes after administration	Yes
Secondary	Duration of hyperglycemic effect of glucagon		Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration	Yes

External Links

•   DiaCon group focuses on developing new technologies for treatment of type 1 diabetes