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Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes (GluST1)

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ClinicalTrials.gov Identifier: NCT02232971
Recruitment Status : Unknown
Verified March 2015 by Ajenthen Ranjan, Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2014
Last Update Posted : March 25, 2015
Sponsor:
Collaborators:
The Novo Nordic Foundation
University of Copenhagen
Information provided by (Responsible Party):
Ajenthen Ranjan, 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Glucagon Other: Isotonic saline solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Placebo Comparator: Placebo
Isotonic Saline
Other: Isotonic saline solution
Placebo
Other Names:
  • Natriumklorid isotonisk "SAD"
  • D.sp.no. 6733
  • Amgros I/S
  • Dampfærgevej 22
  • Postbox 2593
  • 2100 København Ø

Experimental: Glucagon 0.1 mg
GlucaGen(r) 0.1 mg administration
Drug: Glucagon
Glucagon is given in three different doses according to three research days.
Other Names:
  • GlucaGen (r)
  • Disp. no. 2514
  • Novo Nordisk A/S
  • Novo Allé
  • 2880 Bagsværd

Experimental: Glucagon 0.2 mg
GlucaGen(r) 0.2 mg administration
Drug: Glucagon
Glucagon is given in three different doses according to three research days.
Other Names:
  • GlucaGen (r)
  • Disp. no. 2514
  • Novo Nordisk A/S
  • Novo Allé
  • 2880 Bagsværd

Experimental: Glucagon 0.3 mg
GlucaGen(r) 0.3 mg administration
Drug: Glucagon
Glucagon is given in three different doses according to three research days.
Other Names:
  • GlucaGen (r)
  • Disp. no. 2514
  • Novo Nordisk A/S
  • Novo Allé
  • 2880 Bagsværd




Primary Outcome Measures :
  1. Maximum plasma glucose response [ Time Frame: Plasma glucose measured every five minutes after administration ]

Secondary Outcome Measures :
  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 ]

Other Outcome Measures:
  1. Plasma Catecholamine [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  2. Plasma free fatty acids [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  3. Plasma Beta-Hydroxybutyric acid [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  4. Plasma Glucagon [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  5. Serum Growth hormone [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  6. Serum Cortisol [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  7. Serum Insulin (Novorapid) [ Time Frame: Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration ]
  8. Adverse reaction: Stomach pain [ 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. ]
    Visual analog scale

  9. Adverse reaction: Headache [ 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. ]
    Visual Analog scale

  10. Adverse Reaction: Vertigo [ 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. ]
    Visual analog scale

  11. Adverse reaction: Nausea [ 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. ]
    Visual analog scale

  12. Adverse reaction: Hunger [ 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. ]
    Visual analog scale

  13. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232971


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
The Novo Nordic Foundation
University of Copenhagen
Investigators
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Principal Investigator: Ajenthen Ranjan, MD Hvidovre University Hospital
Study Director: Signe Schmidt, MD, PhD Hvidovre University Hospital
Study Chair: Kirsten Nørgaard, MD, DMSc Hvidovre University Hospital
Study Chair: Sten Madsbad, Prof, DMSc Hvidovre University Hospital
Study Chair: Jens J Holst, Prof, DMSc University of Copenhagen

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Responsible Party: Ajenthen Ranjan, MD, PhD student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02232971     History of Changes
Other Study ID Numbers: GluST1_2014
2014-002267-15 ( EudraCT Number )
H-1-2014-041 ( Other Identifier: The National Committee on Health Research Ethics )
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Ajenthen Ranjan, Hvidovre University Hospital:
glucagon
insulin pump
artificial pancreas
closed-loop

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins