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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002267-15 | EudraCT Number | ||
| H-1-2014-041 | Other Identifier | The National Committee on Health Research Ethics |
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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Isotonic Saline |
|
| Glucagon 0.1 mg | Experimental | GlucaGen(r) 0.1 mg administration |
|
| Glucagon 0.2 mg | Experimental | GlucaGen(r) 0.2 mg administration |
|
| Glucagon 0.3 mg | Experimental | GlucaGen(r) 0.3 mg administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon | Drug | Glucagon is given in three different doses according to three research days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma glucose response | Plasma glucose measured every five minutes after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hyperglycemic effect of glucagon | Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Catecholamine | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration | |
| Plasma free fatty acids | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajenthen Ranjan, MD | Hvidovre University Hospital | Principal Investigator |
| Signe Schmidt, MD, PhD | Hvidovre University Hospital | Study Director |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Isotonic saline solution | Other | Placebo |
|
|
| Plasma Beta-Hydroxybutyric acid | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| Plasma Glucagon | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| Serum Growth hormone | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| Serum Cortisol | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| Serum Insulin (Novorapid) | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Plasma triglycerides | Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004763 | Glucagon-Like Peptides |
| D005768 | Gastrointestinal Hormones |