| Trial ID: | L5405 |
| Source ID: | NCT01915849
|
| Associated Drug: |
Lik066
|
| Title: |
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01915849/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: LIK066|DRUG: Placebo
|
| Outcome Measures: |
Primary: Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose, Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation., Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4) |
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
|
| Start Date: |
2013-07
|
| Completion Date: |
2014-01
|
| Results First Posted: |
2015-02-06
|
| Last Update Posted: |
2015-02-06
|
| Locations: |
Novartis Investigative Site, Chula Vista, California, 91910, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01915849
|
