Phase 2
Completed N=54
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Source: ClinicalTrials.gov NCT03198767 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Number of Episodes of Diarrhea (Part A and Part B) — 1.67; 1.25; 0.38; 1.88 Number of stools — p=0.202
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Episodes of Diarrhea (Part A and Part B) |
1.67; 1.25; 0.38; 1.88; 1.46; 1.46 | 0.202 |
| SECONDARY Three-day Total Number of Episodes of Diarrhea (Part A and Part B) |
3.96; 2.83; 1.50; 4.42; 3.46; 4.00 | 0.040 sig |
| SECONDARY Average Consistency With Bristol Stool Chart (Part A and Part B) |
5.45; 5.42; 4.71; 5.81; 5.52; 5.62 | 0.426 |
| SECONDARY Average Stool pH (Part A and Part B) |
6.35; 6.50; 6.29; 6.52; 6.79; 6.66 | — |
| SECONDARY Average Stool Weight (Part A and Part B) |
136.5; 154.5; 116.7; 145.5; 177.1; 164.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03198767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.