Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, 4-part, Interwoven Single- and Multiple-ascending Dose Study to Assess Safety, Tolerability, PK and PD of LIK066 in Healthy Subjects and in Patients With T2DM

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Drug: LIK066
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parts I and III: Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening. Parts II and IV: Patients, age 18-65 years, must have been diagnosed with T2DM at least 8 weeks prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening. Fasting plasma glucose ≤250mg/dL at screening and baseline. If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study. Exclusion Criteria; all parts: Patients with type 1 diabetes mellitus. Patients with history of acute diabetic complications within the 6 months prior to screening. Women of child-bearing potential. Patients with signs or symptoms of significant diabetic complications. Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing. History of drug or alcohol abuse within the 12 months prior to dosing. Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIK066 in healthy subjects<br> | Drug: LIK066<br>* Participants will receive a single or multiple doses of LIK066<br>|
| Placebo Comparator: Matching placebo in healthy subjects<br> | Drug: Placebo<br>* Participants will receive a single or multiple doses of a matching placebo<br>|
| Experimental: LIK066 in patients with type 2 diabetes mellitus<br> | Drug: LIK066<br>* Participants will receive a single or multiple doses of LIK066<br>|
| Placebo Comparator: Matching placebo in patients with type 2 diabetes mellitus<br> | Drug: Placebo<br>* Participants will receive a single or multiple doses of a matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment |  | Baseline and End of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, blood glucose, OGTT, LIK066