Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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). [Daily during treatment]
Secondary Outcome Measures
- Change in fasting and post-challenge plasma glucose after 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 a single dose and 2 weeks of treatment [Baseline and End of Treatment]
Eligibility Criteria
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.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Miami | Florida | United States | 33126 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CLIK066X2101