Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT01407003
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2011-06-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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LIK066 in healthy subjects
LIK066
Participants will receive a single or multiple doses of LIK066
Matching placebo in healthy subjects
Placebo
Participants will receive a single or multiple doses of a matching placebo
LIK066 in patients with type 2 diabetes mellitus
LIK066
Participants will receive a single or multiple doses of LIK066
Matching placebo in patients with type 2 diabetes mellitus
Placebo
Participants will receive a single or multiple doses of a matching placebo
Interventions
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LIK066
Participants will receive a single or multiple doses of LIK066
Placebo
Participants will receive a single or multiple doses of a matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Miami, Florida, United States
Countries
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Related Links
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Results for CLIK066X2101 from the Novartis Clinical Trials website
Other Identifiers
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CLIK066X2101
Identifier Type: -
Identifier Source: org_study_id