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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005793-63 | EudraCT Number |
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The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIK066 2.5 mg | Experimental | Patients receive 2.5 mg of LIK066 once daily for 12 weeks |
|
| LIK066 5 mg | Experimental | Patients receive 5 mg of LIK066 once daily for 12 weeks |
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| LIK066 10 mg | Experimental | Patients receive 10 mg of LIK066 once daily for 12 weeks |
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| LIK066 25 mg | Experimental | Patients receive 25 mg of LIK066 once daily for 12 weeks |
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| LIK066 50 mg | Experimental | Patients receive 50 mg of LIK066 once daily for 12 weeks |
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| LIK066 100 mg | Experimental | Patients receive 100 mg of LIK066 once daily for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | Experimental treatment doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks | Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fasting Plasma Glucose | The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in urinary glucose to creatinine ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000709456 | licogliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| LIK066 150 mg | Experimental | Patients receive 150 mg of LIK066 once daily for 12 weeks |
|
| Sitagliptin 100 mg | Active Comparator | Patients receive 100 mg sitagliptin once daily for 12 weeks |
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| Placebo | Placebo Comparator | Patients receive placebo for 12 weeks |
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| Sitagliptin | Drug | Active comparator treatment dose |
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| Placebo | Drug | Placebo comparator dose |
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The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated
| baseline, 12 weeks |
| Change from baseline in Body weight | The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in Blood pressure | The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in postprandial glucose during a meal test | The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in beta cell function during a meal test | The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in insulin secretion relative to glucose during a meal test | The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in oral glucose insulin sensitivity during a meal test | The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in glucagon-like peptide response during a meal test | The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Change from baseline in Peptide YY response during a meal test | The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated. | baseline, 12 weeks |
| Number of patients with adverse events to assess safety and tolerability of LIK066 | The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death. | 12 weeks |
| Change from baseline in renal threshold for glucose excretion | The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection | baseline, 12 weeks |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |