Trial Outcomes & Findings for Fatty Liver Study in Patients With Type II Diabetes (NCT NCT02365233)
NCT ID: NCT02365233
Last Updated: 2018-07-31
Results Overview
Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.
TERMINATED
PHASE4
5 participants
Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.
2018-07-31
Participant Flow
Before randomization to obtain the intervention, eligibility criteria were verified based on an A1c test, pregnancy test and liver ultrasound to confirm fatty liver. IRB withheld the data due to inadequate supporting documentation.
Participant milestones
| Measure |
Thiazolidinedione
(Pioglitazone, 15 mg/day)
Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
Lantus Insulin
0.35 U per kg body weight once daily
Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
DPP4 Inhibitor
Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day
DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Thiazolidinedione
(Pioglitazone, 15 mg/day)
Pioglitazone: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
Lantus Insulin
0.35 U per kg body weight once daily
Lantus insulin: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
DPP4 Inhibitor
Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day
DPP4 inhibitor: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
|
|---|---|---|---|
|
Overall Study
IRB withheld the data
|
1
|
2
|
2
|
Baseline Characteristics
Fatty Liver Study in Patients With Type II Diabetes
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.Population: IRB withheld the data due to inadequate supporting documentation
Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.
Outcome measures
Outcome data not reported
Adverse Events
Thiazolidinedione
Lantus Insulin
DPP4 Inhibitor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicola Abate, MD - Professor and Director of Endocrinology Division
University of Texas Medical Branch
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place