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Error made by local pharmacy caused mixed randomization of 20 participants
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liraglutide | Active Comparator | liraglutide 1.8 mg injected once daily |
|
| Placebo injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | liraglutide titrated to 1.8 mg sc daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1c | Baseline to 24 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients experiencing hypoglycemia | Baseline and 24 weeks | |
| Change in Systolic Blood pressure | Baseline and 24 weeks | |
| Change in diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent C Woo, MD FRCPC | University of Mantioba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group | Winnipeg | Manitoba | R3E3P4 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| 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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| placebo injection | Drug | placebo injected sc daily volume equal to active comparator |
|
|
| Baseline and 24 weeks |
| Change in waist circumference | Baseline and 24 weeks |
| Change in body weight | Baseline and 24 weeks |
| Change in heart rate | Baseline and 24 weeks |
| Change in lipid profile | Baseline and 24 weeks |
| Diabetes Treatment Satisfaction | Baseline, 12 weeks and 24 weeks |
| Percentage of patients achieving A1C < or equal to 7% | Baseline and 24 weeks |
| Change in fasting blood glucose | Baseline adn 24 weeks |
| Occurence of undetected hypoglycemia as measured by continuous glucose monitoring | Baseline, 12 weeks and 24 weeks |
| Postprandial glucose reduction through measurement of 7 point glucose profile | Baseline, 4 weeks, 12 weeks and 24 weeks |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |