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The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate |
|
| Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate |
|
| Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate |
|
| Part A: LIK066 + P1: 8% CHO | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | LIK066 50 mg tablets. Open-label, bulk, blister-pack. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Episodes of Diarrhea (Part A and Part B) | Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal. | 24 hours on Day 3 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Three-day Total Number of Episodes of Diarrhea (Part A and Part B) | Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal. | Day 1 to 3 of each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 116 subjects were screened and 54 subjects were enrolled and randomized, with 48 completing the study. 6 subjects in Part A were discontinued due to a protocol deviation after day 3 dosing (the protein drink provided to subjects was incorrect and included 8% carbohydrate).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate |
| FG001 | Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate |
| FG002 | Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate |
| FG003 | Part A: LIK066 + P1: 8% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1. |
| FG004 | Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) |
| FG005 | Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) |
| FG006 | Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set. All subjects that received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate |
| BG001 | Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Analysis Set |
| 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 | Number of Episodes of Diarrhea (Part A and Part B) | Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal. | PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data. | Posted | Mean | Standard Deviation | Number of stools | 24 hours on Day 3 of each treatment period |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: LIK066 + 50% CHO | Part A: LIK066 + 50% carbohydrate CHO | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2017 | Aug 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2017 | Aug 27, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000709456 | licogliflozin |
| D011620 | Psyllium |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) |
|
| Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) |
|
| Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS | Experimental | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) |
|
| Carbohydrate 50% | Dietary Supplement | 50% carbohydrate in breakfast meal |
|
| Carbohydrate 25% | Dietary Supplement | 25% carbohydrate in breakfast meal |
|
| Carbohydrate 8% | Dietary Supplement | 8% carbohydrate in breakfast meal |
|
| Carbohydrate 0% | Dietary Supplement | 0% carbohydrate in breakfast meal |
|
| Psyllium | Dietary Supplement | Powder 6 grams |
|
|
| Calcium carbonate | Dietary Supplement | Liquid 1 gram (4 mL equivalent sugar free) |
|
|
| Average Consistency With Bristol Stool Chart (Part A and Part B) | BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool). | 24 hours on Day 3 of each treatment period |
| Average Stool pH (Part A and Part B) | Average PH of Stool at day 3 | 24 hours on Day 3 of each treatment period |
| Average Stool Weight (Part A and Part B) | 24 hour average stool weight on day 3 | 24 hours on Day 3 of each treatment period |
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate |
| BG002 | Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate |
| BG003 | Part A: LIK066 + P1: 8% CHO | Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1. |
| BG004 | Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) |
| BG005 | Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) |
| BG006 | Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS | Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) |
| BG007 | Total | Total of all reporting groups |
| Full Range |
| Years |
|
| Sex: Female, Male | Safety Analysis Set | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Safety Analysis Set | Count of Participants | Participants |
|
Part A: LIK066 + 25% carbohydrate CHO
| OG002 | Part A: LIK066 + 0% CHO | Part A: LIK066 + 0% carbohydrate CHO |
| OG003 | Part B: LIK066 + 50% CHO + NS | Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) |
| OG004 | Part B: LIK066 + 50% CHO + PS | Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) |
| OG005 | Part B: LIK066 + 50% CHO CC | Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) |
|
|
|
| Secondary | Three-day Total Number of Episodes of Diarrhea (Part A and Part B) | Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal. | PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data. | Posted | Mean | Standard Deviation | Number of stools | Day 1 to 3 of each treatment period |
|
|
|
|
| Secondary | Average Consistency With Bristol Stool Chart (Part A and Part B) | BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool). | PD Analysis Set. | Posted | Mean | Standard Deviation | score | 24 hours on Day 3 of each treatment period |
|
|
|
|
| Secondary | Average Stool pH (Part A and Part B) | Average PH of Stool at day 3 | PD Analysis Set | Posted | Mean | Standard Deviation | pH | 24 hours on Day 3 of each treatment period |
|
|
|
| Secondary | Average Stool Weight (Part A and Part B) | 24 hour average stool weight on day 3 | PD Analysis Set | Posted | Mean | Standard Deviation | gram | 24 hours on Day 3 of each treatment period |
|
|
|
| 24 |
| 0 |
| 24 |
| 21 |
| 24 |
| EG001 | Part A: LIK066 + 25% CHO | Part A: LIK066 + 25% carbohydrate CHO | 0 | 24 | 0 | 24 | 19 | 24 |
| EG002 | Part A: LIK066 + 0% CHO | Part A: LIK066 + 0% carbohydrate CHO | 0 | 24 | 0 | 24 | 19 | 24 |
| EG003 | Part A: LIK066 + 8% CHO | Part A: LIK066 + 8% carbohydrate CHO | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Part B: LIK066 + 50% CHO + NS | Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) | 0 | 24 | 0 | 24 | 21 | 24 |
| EG005 | Part B: LIK066 + 50% CHO + PS | Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) | 0 | 24 | 0 | 24 | 19 | 24 |
| EG006 | Part B: LIK066 + 50% CHO CC | Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) | 0 | 24 | 0 | 24 | 22 | 24 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 20.1 | 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 (ie, data from all sites) in the clinical trial.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D017610 |
| Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| Ratio of number of events |
| 0.37 |
| 2-Sided |
| 80 |
| 0.28 |
| 0.49 |
| Superiority |
| Mixed Models Analysis | 0.008 | Ratio of number of events | 0.54 | 2-Sided | 80 | 0.41 | 0.72 | Superiority |
| Mixed Models Analysis | 0.141 | Ratio of number of events | 0.79 | 2-Sided | 80 | 0.65 | 0.97 | Superiority |
| Mixed Models Analysis | 0.510 | Ratio of number of events | 0.90 | 2-Sided | 80 | 0.74 | 1.10 | Superiority |
| Mixed Models Analysis | 0.401 | Ratio of number of events | 1.14 | 2-Sided | 80 | 0.93 | 1.41 | Superiority |
| Median Difference (Final Values) |
| -1.06 |
| 2-Sided |
| 80 |
| -1.46 |
| -0.67 |
| Superiority |
| Mixed Models Analysis | 0.009 | Mean Difference (Final Values) | -0.85 | 2-Sided | 80 | -1.25 | -0.45 | Superiority |
| Mixed Models Analysis | 0.135 | Mean Difference (Final Values) | -0.37 | 2-Sided | 80 | -0.68 | -0.05 | Superiority |
| Mixed Models Analysis | 0.436 | Median Difference (Final Values) | -0.19 | 2-Sided | 80 | -0.50 | 0.12 | Superiority |
| Mixed Models Analysis | 0.452 | Median Difference (Final Values) | 0.18 | 2-Sided | 80 | -0.13 | 0.49 | Superiority |