| Trial ID: | L4773 |
| Source ID: | NCT01407003
|
| Associated Drug: |
Lik066
|
| Title: |
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: LIK066|DRUG: Placebo
|
| Outcome Measures: |
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|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
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
138
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2011-06
|
| Completion Date: |
2013-02
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-19
|
| Locations: |
Novartis Investigative Site, Miami, Florida, 33126, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01407003
|
