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

Novartis

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: Carbohydrate 0%; Dietary Supplement: Carbohydrate 8%; Dietary Supplement: Carbohydrate 50%; Dietary Supplement: Psyllium; Drug: LIK066; Dietary Supplement: Calcium carbonate; Dietary Supplement: Carbohydrate 25%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198767

CLIK066B2203

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 7 patient groups

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

Experimental group

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

Treatment:

Dietary Supplement: Carbohydrate 50%

Dietary Supplement: Carbohydrate 25%

Drug: LIK066

Dietary Supplement: Carbohydrate 0%

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

Experimental group

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

Treatment:

Dietary Supplement: Carbohydrate 50%

Dietary Supplement: Carbohydrate 25%

Drug: LIK066

Dietary Supplement: Carbohydrate 0%

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

Experimental group

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

Treatment:

Dietary Supplement: Carbohydrate 50%

Dietary Supplement: Carbohydrate 25%

Drug: LIK066

Dietary Supplement: Carbohydrate 0%

Part A: LIK066 + P1: 8% CHO

Experimental group

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.

Treatment:

Dietary Supplement: Carbohydrate 8%

Drug: LIK066

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

Experimental group

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)

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Carbohydrate 50%

Drug: LIK066

Dietary Supplement: Psyllium

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

Experimental group

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)

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Carbohydrate 50%

Drug: LIK066

Dietary Supplement: Psyllium

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

Experimental group

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)

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Carbohydrate 50%

Drug: LIK066

Dietary Supplement: Psyllium