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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002526-67 | EudraCT Number |
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| Name | Class |
|---|---|
| NNF Center for Basal Metabolic Research, Denmark | UNKNOWN |
| Hillerod Hospital, Denmark | OTHER |
| Danish PhD schools of Molecular Metabolism and Endocrinology | OTHER |
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The purpose of this study is to:
Part 1:
To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.
Part 2:
To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Insulin + Study 2 | Placebo Comparator | Study 2: Cognitive performance test |
|
| Liraglutide + Insulin + Study 2 | Experimental | Study 2: Cognitive performance test |
|
| Liraglutide + Insulin + Study 1 | Experimental | Study 1: Gastric emptying test |
|
| Placebo + Insulin + Study 1 | Placebo Comparator | Study 1: Gastric emptying test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c (glycosylated haemoglobin) | Week 0, week 12 | |
| Changes from baseline in EEG and cognitive performances | week 0, week 12 | |
| Change from baseline in gastric emptying rate | week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glycemic control (CGM) | week 0, week 12 | |
| Change from baseline in total daily insulin dose | week 0, week 12 | |
| Changes from baseline in the counterregulatory hormone responses during hypoglycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Hypoglycemic episodes | Week 0, week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian SS Frandsen, MD | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Endocrinology, Hvidovre University Hospital | Hvidovre | Copenhagen | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26486191 | Derived | Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study. Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune 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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| Novo Nordisk A/S |
| INDUSTRY |
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| Placebo | Drug | Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed. |
|
| Liraglutide | Drug | Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed. |
|
| Placebo | Drug | Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed. |
|
| week 0, week 12 |
| Change from baseline in body weight | week 0, week 12 |
| Change from baseline in auditory evoked potentials (AEP) during hypoglycemia | week 0, week 12 |
| Change from baseline in corrected QTc-interval (QTc) during hypoglycemia | week 0, week 12 |
| Change from baseline in hypoglycemic symptom score | week 0, week 12 |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |