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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407003
First Posted: August 1, 2011
Last Update Posted: May 13, 2014
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.

Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM) Drug: LIK066 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 138
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIK066 in healthy subjects Drug: LIK066
Participants will receive a single or multiple doses of LIK066
Placebo Comparator: Matching placebo in healthy subjects Drug: Placebo
Participants will receive a single or multiple doses of a matching placebo
Experimental: LIK066 in patients with type 2 diabetes mellitus Drug: LIK066
Participants will receive a single or multiple doses of LIK066
Placebo Comparator: Matching placebo in patients with type 2 diabetes mellitus Drug: Placebo
Participants will receive a single or multiple doses of a matching placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407003


Locations
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01407003     History of Changes
Other Study ID Numbers: CLIK066X2101
First Submitted: July 20, 2011
First Posted: August 1, 2011
Last Update Posted: May 13, 2014
Last Verified: April 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
T2DM, blood glucose, OGTT, LIK066

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases