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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407003
• Other study ID #: CLIK066X2101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• LIK066
Participants will receive a single or multiple doses of LIK066
• Placebo
Participants will receive a single or multiple doses of a matching placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Daily during treatment
Secondary	Change in fasting and post-challenge plasma glucose after 2 weeks of treatment		Baseline and End of Treatment
Secondary	Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration		Day 1 and End of Treatment
Secondary	Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment		Baseline and End of Treatment

External Links

•   Results for CLIK066X2101 from the Novartis Clinical Trials website