Trial Outcomes & Findings for Study of INT-747 in Patients With Diabetes and Presumed NAFLD (NCT NCT00501592)
NCT ID: NCT00501592
Last Updated: 2012-04-20
Results Overview
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
baseline and 6 weeks
Results posted on
2012-04-20
Participant Flow
Sixty four subjects were enrolled in the study at 4 sites. Of the randomized subjects, 20 were randomized to INT-747 25 mg, 21 subjects to INT-747 50 mg, and 23 subjects to placebo. Study enrollment by center ranged from 4 to 31 subjects.
A protocol amendment allowed for the enrollment of 14 replacement subjects (to enroll up to 56 subjects meeting eligibility requirements). The amendment pre-specified that the original 14 subjects being replaced would not be included in the efficacy analysis since they did not meet the protocol requirements.
Participant milestones
| Measure |
25 mg INT-747
Once daily by mouth
|
50 mg INT-747
Once daily by mouth
|
Placebo
Once daily by mouth
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
23
|
|
Overall Study
COMPLETED
|
20
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Baseline characteristics by cohort
| Measure |
25 mg INT-747
n=20 Participants
Once daily by mouth
|
50 mg INT-747
n=21 Participants
Once daily by mouth
|
Placebo
n=23 Participants
Once daily by mouth
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age Continuous
|
52.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
23 participants
n=5 Participants
|
64 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 weeksThe primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
Outcome measures
| Measure |
25 mg INT-747
n=20 Participants
Once daily by mouth
|
50 mg INT-747
n=21 Participants
Once daily by mouth
|
Placebo
n=23 Participants
Once daily by mouth
|
|---|---|---|---|
|
Insulin Resistance and Glucose Homeostasis
Low Dose Insulin
|
.69 mg/kg/min
Standard Deviation 1.12
|
.24 mg/kg/min
Standard Deviation 1.62
|
-0.51 mg/kg/min
Standard Deviation 1.88
|
|
Insulin Resistance and Glucose Homeostasis
High Dose Insulin
|
.73 mg/kg/min
Standard Deviation 1.53
|
.42 mg/kg/min
Standard Deviation 1.42
|
-0.61 mg/kg/min
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: baseline and 6 weeksHepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function
Outcome measures
| Measure |
25 mg INT-747
n=20 Participants
Once daily by mouth
|
50 mg INT-747
n=21 Participants
Once daily by mouth
|
Placebo
n=23 Participants
Once daily by mouth
|
|---|---|---|---|
|
Hepatocellular Function
ALT
|
-9 U/L
Standard Deviation 14
|
9 U/L
Standard Deviation 47
|
11 U/L
Standard Deviation 48
|
|
Hepatocellular Function
AST
|
-3 U/L
Standard Deviation 7
|
4 U/L
Standard Deviation 24
|
4 U/L
Standard Deviation 46
|
|
Hepatocellular Function
GGT
|
-39 U/L
Standard Deviation 77
|
-23 U/L
Standard Deviation 56
|
5 U/L
Standard Deviation 27
|
Adverse Events
25 mg INT-747
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg INT-747
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg INT-747
n=20 participants at risk
Once daily by mouth
|
50 mg INT-747
n=21 participants at risk
Once daily by mouth
|
Placebo
n=23 participants at risk
Once daily by mouth
|
|---|---|---|---|
|
General disorders
Vessel Puncture Site Pain
|
5.0%
1/20 • Number of events 1 • One year, 7 monhts
|
19.0%
4/21 • Number of events 6 • One year, 7 monhts
|
8.7%
2/23 • Number of events 3 • One year, 7 monhts
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • One year, 7 monhts
|
23.8%
5/21 • Number of events 5 • One year, 7 monhts
|
0.00%
0/23 • One year, 7 monhts
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 2 • One year, 7 monhts
|
14.3%
3/21 • Number of events 5 • One year, 7 monhts
|
4.3%
1/23 • Number of events 2 • One year, 7 monhts
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Number of events 2 • One year, 7 monhts
|
4.8%
1/21 • Number of events 1 • One year, 7 monhts
|
8.7%
2/23 • Number of events 2 • One year, 7 monhts
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • One year, 7 monhts
|
4.8%
1/21 • Number of events 1 • One year, 7 monhts
|
8.7%
2/23 • Number of events 2 • One year, 7 monhts
|
|
General disorders
Pyrexia
|
0.00%
0/20 • One year, 7 monhts
|
0.00%
0/21 • One year, 7 monhts
|
8.7%
2/23 • Number of events 2 • One year, 7 monhts
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • One year, 7 monhts
|
0.00%
0/21 • One year, 7 monhts
|
8.7%
2/23 • Number of events 2 • One year, 7 monhts
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • One year, 7 monhts
|
0.00%
0/21 • One year, 7 monhts
|
8.7%
2/23 • Number of events 2 • One year, 7 monhts
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Number of events 2 • One year, 7 monhts
|
0.00%
0/21 • One year, 7 monhts
|
0.00%
0/23 • One year, 7 monhts
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/20 • One year, 7 monhts
|
4.8%
1/21 • Number of events 1 • One year, 7 monhts
|
0.00%
0/23 • One year, 7 monhts
|
Additional Information
Cathi Sciacca, Sr. Director, Clinical Operations
Intercept Pharmaceuticals, Inc.
Phone: 858-652-6800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All proposed publications based on this study shall be approved by the Sponsor prior to submission for publication. Such approval will not be unreasonably witheld. Publications will reflect the contributions made by the Investigators, Sponsor personnel and other groups involved in the study.
- Publication restrictions are in place
Restriction type: OTHER