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

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ClinicalTrials.gov Identifier: NCT03198767
Recruitment Status : Completed
First Posted : June 26, 2017
Results First Posted : September 25, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: LIK066 Dietary Supplement: Carbohydrate 50% Dietary Supplement: Carbohydrate 25% Dietary Supplement: Carbohydrate 8% Dietary Supplement: Carbohydrate 0% Dietary Supplement: Psyllium Dietary Supplement: Calcium carbonate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : June 21, 2017
Actual Primary Completion Date : September 4, 2017
Actual Study Completion Date : September 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 0%
0% carbohydrate in breakfast meal

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
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 0%
0% carbohydrate in breakfast meal

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
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 0%
0% carbohydrate in breakfast meal

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.
Drug: LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Dietary Supplement: Carbohydrate 8%
8% carbohydrate in breakfast meal

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)
Drug: LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Dietary Supplement: Carbohydrate 50%
50% carbohydrate in breakfast meal

Dietary Supplement: Psyllium
Powder 6 grams
Other Name: MetaMucil®

Dietary Supplement: Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Other Name: Quality Value®

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)
Drug: LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Dietary Supplement: Carbohydrate 50%
50% carbohydrate in breakfast meal

Dietary Supplement: Psyllium
Powder 6 grams
Other Name: MetaMucil®

Dietary Supplement: Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Other Name: Quality Value®

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)
Drug: LIK066
LIK066 50 mg tablets. Open-label, bulk, blister-pack.

Dietary Supplement: Carbohydrate 50%
50% carbohydrate in breakfast meal

Dietary Supplement: Psyllium
Powder 6 grams
Other Name: MetaMucil®

Dietary Supplement: Calcium carbonate
Liquid 1 gram (4 mL equivalent sugar free)
Other Name: Quality Value®




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198767


Locations
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United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] August 8, 2017
Statistical Analysis Plan  [PDF] September 27, 2017


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03198767     History of Changes
Other Study ID Numbers: CLIK066B2203
First Posted: June 26, 2017    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: June 11, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
obesity
overweight
body mass index
BMI
diarrhea
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Calcium, Dietary
Calcium Carbonate
Psyllium
Calcium polycarbophil
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Cathartics
Antidiarrheals