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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005317-39 | EudraCT Number | ||
| U1111-1137-3221 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| Steno Diabetes Center Copenhagen | OTHER |
| Hillerod Hospital, Denmark | OTHER |
| Bispebjerg Hospital | OTHER |
| Odense University Hospital |
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The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | 1.8 mg |
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| Saline | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell function | To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucagon | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in: HbA1c. | 52 weeks |
| Insulin dose | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change ininsulin dose. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sten Madsbad, Professor | Hvidovre University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Endocrinology, Hvidovre University Hospital | Hvidovre | Capital | 2650 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
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| Drug |
Saline |
|
| 52 weeks |
| Weight | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in weight. | 52 weeks |
| Remission period | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in length of insulin remission period. | 52 weeks |
| Hypoglycemia | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in frequency of hypoglycaemic events. | 52 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |