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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 4, 2017

Interventions

  • Drug: LIK066
    • LIK066 50 mg tablets. Open-label, bulk, blister-pack.
  • Dietary Supplement: Carbohydrate 50%
    • 50% carbohydrate in breakfast meal
  • Dietary Supplement: Carbohydrate 25%
    • 25% carbohydrate in breakfast meal
  • Dietary Supplement: Carbohydrate 8%
    • 8% carbohydrate in breakfast meal
  • Dietary Supplement: Carbohydrate 0%
    • 0% carbohydrate in breakfast meal
  • Dietary Supplement: Psyllium
    • Powder 6 grams
  • Dietary Supplement: Calcium carbonate
    • Liquid 1 gram (4 mL equivalent sugar free)

Arms, Groups and Cohorts

  • Experimental: Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
    • 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
  • Experimental: Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
    • 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
  • Experimental: Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
    • 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
  • Experimental: Part A: LIK066 + P1: 8% CHO
    • 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.
  • Experimental: Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
    • 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)
  • Experimental: Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
    • 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)
  • Experimental: Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Episodes of Diarrhea (Part A and Part B)
    • Time Frame: 24 hours on Day 3 of each treatment period
    • 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.

Secondary Measures

  • Three-day Total Number of Episodes of Diarrhea (Part A and Part B)
    • Time Frame: Day 1 to 3 of each treatment period
    • 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.
  • Average Consistency With Bristol Stool Chart (Part A and Part B)
    • Time Frame: 24 hours on Day 3 of each treatment period
    • BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).
  • Average Stool pH (Part A and Part B)
    • Time Frame: 24 hours on Day 3 of each treatment period
    • Average PH of Stool at day 3
  • Average Stool Weight (Part A and Part B)
    • Time Frame: 24 hours on Day 3 of each treatment period
    • 24 hour average stool weight on day 3

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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