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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: LIK066; Drug: Placebo

• Registration Number: NCT01407003
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Disposition First Submitted: 2014-03-27
• Disposition First Submitted QC: 2014-03-27
• Status Verified: 2014-04
• Disposition First Posted: 2014-04-24
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIK066 in healthy subjects	LIK066	-
Matching placebo in healthy subjects	Placebo	-
LIK066 in patients with type 2 diabetes mellitus	LIK066	-
Matching placebo in patients with type 2 diabetes mellitus	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment	Baseline and End of Treatment
Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration	Day 1 and End of Treatment
Change in fasting and post-challenge plasma glucose after 2 weeks of treatment	Baseline and End of Treatment

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Miami, Florida, United States