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This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIK066 in healthy subjects | Experimental |
| |
| Matching placebo in healthy subjects | Placebo Comparator |
| |
| LIK066 in patients with type 2 diabetes mellitus | Experimental |
| |
| Matching placebo in patients with type 2 diabetes mellitus | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | Participants will receive a single or multiple doses of LIK066 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis). | Daily during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting and post-challenge plasma glucose after 2 weeks of treatment | Baseline and End of Treatment | |
| Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration | Day 1 and End of Treatment |
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Inclusion Criteria:
Exclusion Criteria; all parts:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Miami | Florida | 33126 | United States |
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| Label | URL |
|---|---|
| Results for CLIK066X2101 from the Novartis Clinical Trials website | View source |
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| Placebo | Drug | Participants will receive a single or multiple doses of a matching placebo |
|
| Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment | Baseline and End of Treatment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000709456 | licogliflozin |
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