Clinical trial NCT02470403: Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, 2-part Study Investigating the Effect of LIK066 on Body Weight in Dysglycemic (Prediabetes or Type 2 Diabetes) and Normoglycemic Patients With Elevated Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Elevated Body Mass Index
Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)


Eligibility criteria: Key Inclusion Criteria:

* Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
* Patients with dysglycemia are patients with: Fasting plasma glucose \>100mg/dL (5.6 mmol/L), or HbA1c \> 5.7% and \< 10% at screening.
* Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
* If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
* Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening

Key Exclusion Criteria:

* Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders
* Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption
* Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder
* Pregnant or nursing (lactating) women, and women of child-bearing potential

Primary outcomes:
measure: Part 1: Percent Change in Body Weight From Baseline to Week 12
timeFrame: Baseline, Week 12 (Day 85)
measure: Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death
timeFrame: 12 weeks
measure: Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)
timeFrame: Baseline, Week 2 (Day 14)
measure: Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death
timeFrame: 2 weeks
Secondary outcomes:
measure: Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms
timeFrame: Baseline, Week 2
measure: Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study
timeFrame: Day 84
measure: Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study
timeFrame: Day 84
measure: Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study
timeFrame: Day 84
measure: Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study
timeFrame: Day 84
measure: The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study
timeFrame: Day 84
measure: The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study
timeFrame: Day 84
measure: Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study
timeFrame: Day 1, Day 14
measure: Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study
timeFrame: Day 1, Day 14
measure: Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study
timeFrame: Day 1, Day 14
measure: Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study
timeFrame: Day 1, Day 14
measure: The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study
timeFrame: Day 1, Day 14
measure: The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study
timeFrame: Day 1, Day 14
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
Study officials:
affiliation: Novartis Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: