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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)

Primary Purpose

Type 2 Diabetes Mellitus (T2DM)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LIK066

Placebo

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring T2DM, blood glucose, OGTT, LIK066

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LIK066 in healthy subjects

Matching placebo in healthy subjects

LIK066 in patients with type 2 diabetes mellitus

Matching placebo in patients with type 2 diabetes mellitus

Arm Description

Outcomes

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).

Secondary Outcome Measures

Change in fasting and post-challenge plasma glucose after 2 weeks of treatment

Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration

Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment

Full Information

NCT ID

NCT01407003

First Posted

July 20, 2011

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01407003

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus (T2DM)

Keywords

T2DM, blood glucose, OGTT, LIK066

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIK066 in healthy subjects

Arm Type

Experimental

Arm Title

Matching placebo in healthy subjects

Arm Type

Placebo Comparator

Arm Title

LIK066 in patients with type 2 diabetes mellitus

Arm Type

Experimental

Arm Title

Matching placebo in patients with type 2 diabetes mellitus

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LIK066

Intervention Description

Participants will receive a single or multiple doses of LIK066

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive a single or multiple doses of a matching placebo

Primary Outcome Measure Information:

Title

Time Frame

Daily during treatment

Secondary Outcome Measure Information:

Title

Change in fasting and post-challenge plasma glucose after 2 weeks of treatment

Time Frame

Baseline and End of Treatment

Title

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

Title

Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment

Time Frame

Baseline and End of Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11104

Description

Results for CLIK066X2101 from the Novartis Clinical Trials website

Learn more about this trial

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

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