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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01407003
First received: July 20, 2011
Last updated: April 24, 2014
Last verified: April 2014
  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 Blind (Subject, 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:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in fasting and post-challenge plasma glucose after 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01407003     History of Changes
Other Study ID Numbers: CLIK066X2101
Study First Received: July 20, 2011
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
T2DM, blood glucose, OGTT, LIK066

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

ClinicalTrials.gov processed this record on August 21, 2014