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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01407003
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE August 1, 2011
Last Update Posted Date May 13, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
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). [ Time Frame: Daily during treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2013)
  • Change in fasting and post-challenge plasma glucose after 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ]
  • Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration [ Time Frame: Day 1 and End of Treatment ]
  • Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
  • Change in fasting and post-challenge plasma glucose after 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ]
  • Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration [ Time Frame: Day 1 and End of Treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
Official Title  ICMJE 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
Brief Summary This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Type 2 Diabetes Mellitus (T2DM)
Intervention  ICMJE
  • Drug: LIK066
    Participants will receive a single or multiple doses of LIK066
  • Drug: Placebo
    Participants will receive a single or multiple doses of a matching placebo
Study Arms  ICMJE
  • Experimental: LIK066 in healthy subjects
    Intervention: Drug: LIK066
  • Placebo Comparator: Matching placebo in healthy subjects
    Intervention: Drug: Placebo
  • Experimental: LIK066 in patients with type 2 diabetes mellitus
    Intervention: Drug: LIK066
  • Placebo Comparator: Matching placebo in patients with type 2 diabetes mellitus
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2013)
138
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2011)
162
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407003
Other Study ID Numbers  ICMJE CLIK066X2101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP