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

This study is currently recruiting participants.

Verified July 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01407003

First received: July 20, 2011

Last updated: July 30, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2011

Last Updated Date

July 30, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01407003 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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 *

* 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

Recruiting

Estimated Enrollment ^ICMJE

136

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+41-61-324-1111

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01407003

Other Study ID Numbers ^ICMJE

CLIK066X2101

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

July 2012

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

To Top