Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: LIK066 150 mg once daily (qd) | Experimental | LIK066 150 mg qd within 15 minutes before starting lunch |
|
| Part 1: Placebo once daily | Placebo Comparator | Matching placebo tablets of LCZ696 150 mg within 15 minutes before starting lunch. |
|
| Part 2: LIK066 75 mg twice daily (bid) | Experimental | LIK066 75 mg bid before breakfast and dinner |
|
| Part 2: LIK066 50 mg three times daily (tid) | Experimental | LIK066 50 mg tid before all 3 meals; |
|
| Part 2: Placebo three times daily | Placebo Comparator | Matching placebo tablets tid before meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | LIK066 25 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate. | Baseline, Week 12 (Day 85) |
| Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | This endpoint reports patients with at least one AE (any AE), serious AE and death. | 12 weeks |
| Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. | Baseline, Week 2 (Day 14) |
| Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Lincoln | Nebraska | 68502 | United States |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
Not provided
Subjects were stratified by their glycemic status (dysglycemic or normoglycemic) and randomized to LIK066 or placebo within each stratum in each part of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: LIK066 150 mg Once Daily (qd) | LIK066 150 mg qd within 15 minutes before starting lunch |
| FG001 | Part 1: Placebo Once Daily | Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch. |
| FG002 | Part 2: LIK066 75 mg Twice Daily (Bid) | LIK066 75 mg bid before breakfast and dinner |
| FG003 | Part 2: LIK066 50 mg Three Times Daily (Tid) | LIK066 50 mg tid before all 3 meals; |
| FG004 | Part 2: Placebo Three Times Daily | Matching placebo tablets tid before meals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set included all subjects that received any study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: LIK066 150 mg Once Daily (qd) | LIK066 150 mg qd within 15 minutes before starting lunch |
| BG001 | Part 1: Placebo Once Daily | Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Percent Change in Body Weight From Baseline to Week 12 | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate. | The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement. | Posted | Least Squares Mean | 80% Confidence Interval | percent change | Baseline, Week 12 (Day 85) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: LIK066 150 mg Once Daily (qd) | LIK066 150 mg qd within 15 minutes before starting lunch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709456 | licogliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo tablets |
|
This endpoint reports patients with at least one AE (any AE), serious AE and death
| 2 weeks |
| Baseline, Week 2 |
| Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study | Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | Day 84 |
| Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | Day 84 |
| 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. | Day 84 |
| 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. | Day 84 |
| The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | Day 84 |
| 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | Day 84 |
| Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss) | Day 1, Day 14 |
| Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss) | Day 1, Day 14 |
| Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss) | Day 1, Day 14 |
| Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss) | Day 1, Day 14 |
| The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss) | Day 1, Day 14 |
| The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss) | Day 1, Day 14 |
| Lost to Follow-up |
|
| Subject/guardian decision |
|
| BG002 | Part 2: LIK066 75 mg Twice Daily (Bid) | LIK066 75 mg bid before breakfast and dinner |
| BG003 | Part 2: LIK066 50 mg Three Times Daily (Tid) | LIK066 50 mg tid before all 3 meals; |
| BG004 | Part 2: Placebo Three Times Daily | Matching placebo tablets tid before meals. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Part 1: LIK066 150 mg Once Daily (qd) | LIK066 150 mg qd within 15 minutes before starting lunch |
| OG001 | Part 1: Placebo Once Daily | Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch. |
|
|
|
| Primary | Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | This endpoint reports patients with at least one AE (any AE), serious AE and death. | The safety analysis set included all subjects that received any study drug. | Posted | Number | Patients | 12 weeks |
|
|
|
| Primary | Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. | Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline, Week 2 (Day 14) |
|
|
|
|
| Primary | Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | This endpoint reports patients with at least one AE (any AE), serious AE and death | The safety analysis set included all subjects that received any study drug. | Posted | Number | Patients | 2 weeks |
|
|
|
| Secondary | Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. | The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement. | Posted | Least Squares Mean | 80% Confidence Interval | percent change | Baseline, Week 2 |
|
|
|
| Secondary | Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study | Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 84 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Median | Full Range | hour | Day 84 |
|
|
|
| Secondary | 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 84 |
|
|
|
| Secondary | 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 84 |
|
|
|
| Secondary | The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | Liter/hour | Day 84 |
|
|
|
| Secondary | 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 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | Liter | Day 84 |
|
|
|
| Secondary | Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 14 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Median | Full Range | hour | Day 1, Day 14 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1, Day 14 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1, Day 14 |
|
|
|
| Secondary | The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | Liter/hour | Day 1, Day 14 |
|
|
|
| Secondary | The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study | Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss) | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | Liter | Day 1, Day 14 |
|
|
|
| 1 |
| 44 |
| 43 |
| 44 |
| EG001 | Part 1: Placebo Once Daily | Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch. | 0 | 44 | 39 | 44 |
| EG002 | Part 2: LIK066 75 mg Twice Daily (Bid) | LIK066 75 mg bid before breakfast and dinner | 0 | 40 | 40 | 40 |
| EG003 | Part 2: LIK066 50 mg Three Times Daily (Tid) | LIK066 50 mg tid before all 3 meals; | 0 | 43 | 43 | 43 |
| EG004 | Part 2: Placebo Three Times Daily | Matching placebo tablets tid before meals. | 0 | 10 | 10 | 10 |
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Palatal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Thirst | General disorders | MedDRA | Systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Trichomoniasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Animal scratch | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
|
| Fungal test positive | Investigations | MedDRA | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D004700 | Endocrine System Diseases |
| Death |
|
| This analysis on all subjects. The following criteria were assessed:
| Mixed Models Analysis | <0.001 | Mean Difference (Net) | -2.39 | 2-Sided | 80 | -2.94 | -1.84 | Superiority or Other (legacy) |
| This analysis on all subjects. The following criteria were assessed:
| Mixed Models Analysis | <0.001 | Mean Difference (Net) | -2.38 | 2-Sided | 80 | -2.93 | -1.83 | Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Death |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Day 1, Overall (n= 38, 39) |
|
| Day 14, Dysglycemic (n= 20, 19) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 38) |
|
| Day 1, Overall (n= 38, 39) |
|
| Day 14, Dysglycemic (n= 20, 19) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 38) |
|
| Day 1, Overall (n= 38, 39) |
|
| Day 14, Dysglycemic (n= 20, 19) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 38) |
|
| Day 1, Overall (n= 37, 39) |
|
| Day 14, Dysglycemic (n= 20, 19) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 38) |
|
| Day 1, Overall (n= 37, 39) |
|
| Day 14, Dysglycemic (n= 20, 19) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 38) |
|
| Day 1, Overall (n= 37, 36) |
|
| Day 14, Dysglycemic (n= 20, 16) |
|
| Day 14, Normoglycemic (n= 20, 19) |
|
| Day 14, Overall (n= 40, 35) |
|