A Phase 4 interventional study of Glucagon and Isotonic saline solution in Diabetes Mellitus, Type 1, sponsored by Hvidovre University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Basic science
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 8 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Isotonic Saline
Other: Isotonic saline solution
GlucaGen(r) 0.1 mg administration
Drug: Glucagon
GlucaGen(r) 0.2 mg administration
Drug: Glucagon
GlucaGen(r) 0.3 mg administration
Drug: Glucagon
Glucagon is given in three different doses according to three research days.
Also known as: GlucaGen (r), Disp. no. 2514, Novo Nordisk A/S, Novo Allé, 2880 Bagsværd
Placebo
Also known as: Natriumklorid isotonisk "SAD", D.sp.no. 6733, Amgros I/S, Dampfærgevej 22, Postbox 2593, 2100 København Ø
Maximum plasma glucose response
Time frame: Plasma glucose measured every five minutes after administration
Duration of hyperglycemic effect of glucagon
Time frame: Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration
Plasma Catecholamine
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Plasma free fatty acids
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Plasma Beta-Hydroxybutyric acid
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Plasma Glucagon
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Serum Growth hormone
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Serum Cortisol
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Serum Insulin (Novorapid)
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Adverse reaction: Stomach pain
Visual analog scale
Time frame: 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.
Adverse reaction: Headache
Visual Analog scale
Time frame: 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.
Adverse Reaction: Vertigo
Visual analog scale
Time frame: 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.
Adverse reaction: Nausea
Visual analog scale
Time frame: 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.
Adverse reaction: Hunger
Visual analog scale
Time frame: 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.
Plasma triglycerides
Time frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
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Hvidovre University Hospital