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

• Status: Completed
• Trial end date: 2017-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Calcium; Calcium Carbonate; Licogliflozin; Psyllium

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