Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone
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|ClinicalTrials.gov Identifier: NCT02875821|
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes With Non-alcoholic Fatty Liver (NAFLD)||Drug: Ipragliflozin Drug: metformin with pioglitazone||Phase 4|
Pioglitazone, a peroxisome proliferator-activated receptor-γ (PPARγ) agonist increase insulin sensitivity in peripheral tissue and liver by protecting non-adipose tissues against excessive lipid overload and by balancing the secretion of adipocytokines.
However, PPARγ is a key transcription factor that induces the differentiation adipocyte maturation and stimulates the induction of enzymes involved in lipogenesis. As a result, the effect of pioglitazone is generally accompanied by weight gain and an increase in amount of subcutaneous fat.
Obesity would coexist with fatty liver disease and both conditions aggravate hyperglycemia in diabetes. According to recent study, up-regulated PPARγ expression in liver was reported in obesity with hepatic steatosis which implies pioglitazone might induce fatty liver disease.
A novel oral antidiabetic drug, sodium glucose cotransporter 2 (SGLT2) inhibitor reduces renal glucose reabsorption and increasing renal glucose excretion thereby promoting energy loss. As a result, it prevents weight gain and fluid retention which might counteract the unfavorable effects of pioglitazone treatment.
No study has been conducted on the additional effect on obesity and fatty liver of ipragliflozin in T2DM patients treated with pioglitazone and metformin.
In this study, the investigators investigate beneficial effects of ipragliflozin, newly developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in subjects with T2DM when added to metformin and pioglitazone therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||April 26, 2016|
|Actual Primary Completion Date :||June 7, 2017|
|Actual Study Completion Date :||June 7, 2017|
Experimental: Group IMP
Group IMP (Ipragliflozin with Metformin with Pioglitazone)
Patients treated with ipragliflozin (50 mg/day) as add on therapy to metformin and pioglitazone dual therapy (triple therapy) for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Experimental Group)
Other Name: Suglat®
Active Comparator: Group MP
Group MP (Metformin with Pioglitazone)
Drug: metformin with pioglitazone
Patients maintain metformin and pioglitazone dual therapy for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Control group)
- changes in visceral fat area [ Time Frame: 6 months ]The visceral fat area is measured by dual-energy x-ray absorptiometry (DEXA) at baseline and after 6 months treatment
- Changes in subcutaneous fat area [ Time Frame: 6 months after treatment ]The subcutaneous fat area is measured by dual-energy x-ray absorptiometry (DEXA) and fat computed tomography (CT) at baseline and after 6 months treatment.
- Changes in liver fat [ Time Frame: 6 months after treatment ]Changes in the degree of fatty liver is measured by fibroscan using controlled attenuation parameter (CAP) score.
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): NCT02875821
|Korea, Republic of|
|Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center|
|Seoul, Korea, Republic of, 03722|