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Clinical Trial Details

Trial ID: L6078
Source ID: NCT01824264
Associated Drug: Lik066
Title: Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: LIK066|DRUG: Sitagliptin|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks, Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo, baseline, 12 weeks | Secondary: Change from baseline in Fasting Plasma Glucose, The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in urinary glucose to creatinine ratio, The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated, baseline, 12 weeks|Change from baseline in Body weight, The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in Blood pressure, The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in postprandial glucose during a meal test, The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in beta cell function during a meal test, The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in insulin secretion relative to glucose during a meal test, The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in oral glucose insulin sensitivity during a meal test, The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in glucagon-like peptide response during a meal test, The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Change from baseline in Peptide YY response during a meal test, The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated., baseline, 12 weeks|Number of patients with adverse events to assess safety and tolerability of LIK066, The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death., 12 weeks|Change from baseline in renal threshold for glucose excretion, The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection, baseline, 12 weeks
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-11
Completion Date: 2016-11
Results First Posted:
Last Update Posted: 2014-04-03
Locations:
URL: https://clinicaltrials.gov/show/NCT01824264