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

Phase 2CompletedNCT03198767

Novartis Pharmaceuticals54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

LIK066DRUG

LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Carbohydrate 50%DIETARY_SUPPLEMENT

50% carbohydrate in breakfast meal

Carbohydrate 25%DIETARY_SUPPLEMENT

25% carbohydrate in breakfast meal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 hours on Day 3 of each treatment period

Secondary Outcomes

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.

Time frame: Day 1 to 3 of each treatment period

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).

Time frame: 24 hours on Day 3 of each treatment period

Average Stool pH (Part A and Part B)

Average PH of Stool at day 3

Time frame: 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

Time frame: 24 hours on Day 3 of each treatment period

Data from ClinicalTrials.gov

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