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Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LIK066
Carbohydrate 50%
Carbohydrate 25%
Carbohydrate 8%
Carbohydrate 0%
Psyllium
Calcium carbonate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, overweight, body mass index, BMI, diarrhea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • obese and overweight, BMI 25-50, HbA1C <10%

Exclusion Criteria:

  • Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO

Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO

Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO

Part A: LIK066 + P1: 8% CHO

Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC

Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS

Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS

Arm Description

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

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

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

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.

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)

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Average Stool pH (Part A and Part B)
Average PH of Stool at day 3
Average Stool Weight (Part A and Part B)
24 hour average stool weight on day 3

Full Information

First Posted
June 16, 2017
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03198767
Brief Title
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, overweight, body mass index, BMI, diarrhea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Arm Type
Experimental
Arm Description
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
Arm Title
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Arm Type
Experimental
Arm Description
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
Arm Title
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Arm Type
Experimental
Arm Description
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
Arm Title
Part A: LIK066 + P1: 8% CHO
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Arm Type
Experimental
Arm Description
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)
Arm Title
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Arm Type
Experimental
Arm Description
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)
Arm Title
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
LIK066
Intervention Description
LIK066 50 mg tablets. Open-label, bulk, blister-pack.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate 50%
Intervention Description
50% carbohydrate in breakfast meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate 25%
Intervention Description
25% carbohydrate in breakfast meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate 8%
Intervention Description
8% carbohydrate in breakfast meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate 0%
Intervention Description
0% carbohydrate in breakfast meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Other Intervention Name(s)
MetaMucil®
Intervention Description
Powder 6 grams
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium carbonate
Other Intervention Name(s)
Quality Value®
Intervention Description
Liquid 1 gram (4 mL equivalent sugar free)
Primary Outcome Measure Information:
Title
Number of Episodes of Diarrhea (Part A and Part B)
Description
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.
Time Frame
24 hours on Day 3 of each treatment period
Secondary Outcome Measure Information:
Title
Three-day Total Number of Episodes of Diarrhea (Part A and Part B)
Description
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.
Time Frame
Day 1 to 3 of each treatment period
Title
Average Consistency With Bristol Stool Chart (Part A and Part B)
Description
BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).
Time Frame
24 hours on Day 3 of each treatment period
Title
Average Stool pH (Part A and Part B)
Description
Average PH of Stool at day 3
Time Frame
24 hours on Day 3 of each treatment period
Title
Average Stool Weight (Part A and Part B)
Description
24 hour average stool weight on day 3
Time Frame
24 hours on Day 3 of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: obese and overweight, BMI 25-50, HbA1C <10% Exclusion Criteria: Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
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
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=453
Description
A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066

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