Trial · Interventional
Status unknownPhase 4Registry dataTreatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Short name GluST1
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 8 participants (estimated)
- Sponsor
- Hvidovre University Hospital · Other
- Design
- Randomized · Single masking
- Countries
1 country
Denmark
- Start
- Sept 2014
- Primary completion
- Jan 2015
- Completion
- Jul 2015 (estimated)
- First posted
- 5 Sept 2014 (estimated)
- Last update posted
- 25 Mar 2015 (estimated)
- Conditions
- Diabetes Mellitus, Type 1
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- GlucagonDrug
- Isotonic saline solutionOther
Arms4
Placebo comparator
Placebo
Isotonic Saline
Experimental
Glucagon 0.1 mg
GlucaGen(r) 0.1 mg administration
Experimental
Glucagon 0.2 mg
GlucaGen(r) 0.2 mg administration
Experimental
Glucagon 0.3 mg
GlucaGen(r) 0.3 mg administration
Primary outcomes1
Outcomes the sponsor listed as primary.
Maximum plasma glucose response
Time frame · Plasma glucose measured every five minutes after administration
Secondary outcomes(1)
Duration of hyperglycemic effect of glucagon
Time frame · Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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