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Trial record 22 of 343 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01963845
Recruitment Status : Completed
First Posted : October 16, 2013
Results First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Rohit Loomba, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non-alcoholic Fatty Liver Disease
Interventions Drug: Sitagliptin
Drug: Placebo
Enrollment 50
Recruitment Details Jan. 1, 2014 to May 1, 2015
Pre-assignment Details  
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description Sitagliptin-matched placebo tablet Sitagliptin 100 mg
Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Placebo Active Drug Total
Hide Arm/Group Description Sitagliptin-matched placebo tablet Sitagliptin 100 mg Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  88.0%
21
  84.0%
43
  86.0%
>=65 years
3
  12.0%
4
  16.0%
7
  14.0%
[1]
Measure Description: Subjects recruited from the UCSD hepatology clinic
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
17
  68.0%
12
  48.0%
29
  58.0%
Male
8
  32.0%
13
  52.0%
21
  42.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF
Hide Description Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Sitagliptin-matched placebo tablet

Sitagliptin 100 mg

Sitagliptin

Overall Number of Participants Analyzed 17 24
Mean (Standard Deviation)
Unit of Measure: percentage change in liver fat
13.9  (8.5) 8.4  (11.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Drug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title AST, Aspartate Aminotransferase
Hide Description AST, measured in IU/L at baseline and 24 weeks
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with AST measurements at baseline and 24 weeks
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Sitagliptin-matched placebo tablet

Sitagliptin 100 mg

Sitagliptin

Overall Number of Participants Analyzed 22 25
Median (Inter-Quartile Range)
Unit of Measure: IU/L
Baseline
28.5
(19.0 to 37.0)
28.0
(24.0 to 39.0)
24 weeks
23.5
(19.0 to 30.0)
27.0
(22.0 to 42.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Drug
Comments Comparison of change in AST values from baseline to 24 weeks between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7583
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title ALT, Alanine Aminotransferase
Hide Description ALT, measured in IU/L at baseline and 24 weeks
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with ALT measurements at baseline and 24 weeks
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Sitagliptin-matched placebo tablet

Sitagliptin 100 mg

Sitagliptin

Overall Number of Participants Analyzed 22 25
Median (Inter-Quartile Range)
Unit of Measure: IU/L
Baseline
40.0
(22.0 to 51.0)
43.0
(28.0 to 54.0)
24 weeks
28.5
(20.0 to 50.0)
34.0
(27.0 to 56.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Drug
Comments Comparison of change in ALT values from baseline to 24 weeks between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8569
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title LDL, Low-density Lipoprotein
Hide Description LDL, measured in mg/dL at baseline and 24 weeks
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with LDL measurements at baseline and 24 weeks
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Sitagliptin-matched placebo tablet

Sitagliptin 100 mg

Sitagliptin

Overall Number of Participants Analyzed 22 25
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
99.0
(72 to 134)
100.0
(83.0 to 125.0)
24 weeks
101.0
(76.0 to 131.0)
98.0
(82.0 to 124.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Drug
Comments Comparison of change in LDL values from baseline to 24 weeks between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7984
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title HOMA-IR, Homeostatic Model Assessment of Insulin Resistance
Hide Description HOMA-IR, calculated as [(glucose (mg/dL) X insulin (mg/dL)) / 405 ] at baseline and 24 weeks
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with HOMA-IR calculated at baseline and 24 weeks
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Sitagliptin-matched placebo tablet

Sitagliptin 100 mg

Sitagliptin

Overall Number of Participants Analyzed 22 25
Median (Inter-Quartile Range)
Unit of Measure: HOMA-IR score
Baseline
5.4
(4.3 to 6.8)
5.9
(4.4 to 9.2)
24 weeks
4.9
(2.9 to 8.9)
6.8
(4.4 to 9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Drug
Comments Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5560
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame up to 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description Sitagliptin-matched placebo tablet Sitagliptin 100 mg
All-Cause Mortality
Placebo Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rohit Loomba, MD professor of Medicine
Organization: University of California, San Diego
Phone: 858-543-2230
Responsible Party: Rohit Loomba, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01963845     History of Changes
Other Study ID Numbers: Sitagliptin-NAFLD
First Submitted: October 11, 2013
First Posted: October 16, 2013
Results First Submitted: August 1, 2016
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016