Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
A Randomized, Open Label, Two-part, Three-period, Cross Over Study to Investigate the Effects of Carbohydrate in Diet and to Evaluate Supplements on the Gastrointestinal Tolerability of LIK066 in Overweight or Obese Subjects
1 other identifier
interventional
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Jun 2017
Shorter than P25 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2017
CompletedStudy Start
First participant enrolled
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2017
CompletedResults Posted
Study results publicly available
September 25, 2018
CompletedJanuary 5, 2021
May 1, 2019
3 months
June 16, 2017
August 27, 2018
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Three-day Total Number of Episodes of Diarrhea (Part A and Part B)
Day 1 to 3 of each treatment period
Average Consistency With Bristol Stool Chart (Part A and Part B)
24 hours on Day 3 of each treatment period
Average Stool pH (Part A and Part B)
24 hours on Day 3 of each treatment period
Average Stool Weight (Part A and Part B)
24 hours on Day 3 of each treatment period
Study Arms (7)
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
EXPERIMENTALPeriod 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
EXPERIMENTALPeriod 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
EXPERIMENTALPeriod 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
EXPERIMENTALPeriod 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.
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
EXPERIMENTALPeriod 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
EXPERIMENTALPeriod 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
EXPERIMENTALPeriod 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)
Interventions
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
50% carbohydrate in breakfast meal
25% carbohydrate in breakfast meal
0% carbohydrate in breakfast meal
Powder 6 grams
Liquid 1 gram (4 mL equivalent sugar free)
Eligibility Criteria
You may qualify if:
- obese and overweight, BMI 25-50, HbA1C \<10%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Lincoln, Nebraska, 68502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2017
First Posted
June 26, 2017
Study Start
June 21, 2017
Primary Completion
September 4, 2017
Study Completion
September 4, 2017
Last Updated
January 5, 2021
Results First Posted
September 25, 2018
Record last verified: 2019-05