Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01915849
Last Updated: 2015-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2013-07-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
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Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg
Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
LIK066
LIK066 15 mg, 50 mg and 150 mg
Placebo
Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo
Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
LIK066
LIK066 15 mg, 50 mg and 150 mg
Placebo
Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg
Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
LIK066
LIK066 15 mg, 50 mg and 150 mg
Placebo
Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
LIK066
LIK066 15 mg, 50 mg and 150 mg
Placebo
Interventions
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LIK066
LIK066 15 mg, 50 mg and 150 mg
Placebo
Eligibility Criteria
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Inclusion Criteria
* Fasting plasma glucose ≤250mg/dL at screening.
* 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.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
* 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
No
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
Chula Vista, California, United States
Countries
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Other Identifiers
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CLIK066A2201
Identifier Type: -
Identifier Source: org_study_id
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