Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/27/2018 |
| Start Date: | June 21, 2017 |
| End Date: | September 4, 2017 |
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
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.
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.
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
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