Prospective and randomized controlled study on the efficacy and safety of ipragliflozin and metformin to visceral fat reduction for the patients being treated with DPP-4 inhibitors for poor glycemic controlled type-2 diabetes

Prospective and randomized controlled study on the efficacy and safety of ipragliflozin and metformin to visceral fat reduction for the patients being treated with DPP-4 inhibitors for poor glycemic controlled type-2 diabetes - PRIME-V Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015170

Enrollment

106

Registered

2014-09-21

Start date

2014-09-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Ipragliflozin 50mg Metformin 1000mg (Up to 1500mg)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Type 2 Diabetes (Over 20 and under 75 years of age) (2) Patients who have been unable to adequately control their blood sugar levels despite being administered 50mg of DPP-4 inhibitor sitagliptin for over 12 weeks. (3) HbA1c (NGSP) over 7.0%/under 10.0% (4) BMI over 22kg/m2 (5) eGFR over 50 mL/ min/1.73m2 (6) Patients who have received adequate explanation of the contents of the trial and given their written consent.

Exclusion criteria

Exclusion criteria: (1) Type 1 Diabetes (2) Patients who have experienced metabolic acidosis, diabetic coma and/or pre-coma within six months prior to providing consent (3) Serious infections requiring insulin treatment, prior/upcoming surgeries, and/or severe injuries. (4) Patients with considerable loss of kidney function (creatine blood level of over 1.3mg/dL in men, and over 1.2mg/dL in women) and/or undergoing dialysis (including peritoneal dialysis) (5) Serious liver damage (6) History of stroke, myocardial infarction, heart failure as well as other severe cardiovascular complications requiring hospitalization (7) Patient is taking oral hypoglycemic agents other than DPP-4 inhibitors at the start of the trial. (8) Women who are pregnant or nursing, or could become pregnant (9) History of chemical sensitivity to DPP-4 inhibitors, SGLT2 inhibitors, and/or metformin (10) Suffering or at risk from urinary tract infection and/or dehydration (11) Tested positive for Ketone bodies (12) History of lactic acidosis (13) Excessive alcohol consumption (14) History of osteoporosis (15) Patients who have undergone a CT scan within 3 months prior to providing written consent (16) Determined to be ineligible by the physician in charge for any other reason

Design outcomes

Primary

Measure	Time frame
The change rate of the visceral fat area by CT after 24 weeks therapy in the two groups	—

Secondary

Measure	Time frame
(1) HbA1c (NGSP) (2) Body weight, BMI (3) Waist circumference (4) ALP (BAP), TRACP5b (5) Muscle strength (6) Fasting plasma glucose level, HOMA-b, HOMA-R (7) Cholesterol level (TC, LDL-C, fasting TG, HDL-C) (8) Blood pressure (9) Adipocytokine (adiponectin), inflammatory marker (hs-CRP) (10) Subctaneus fat area, total fat area (11) Respiratory quotient, basal metabolism, whole body DXA, eating behavior questionnaire, calories and glucose amount (12) The change rate of the abdominal muscle area by CT after 24 weeks therapy in the two groups (13) The change rate of the bone density in the fourth lumbar vertebra by CT after 24 weeks therapy in the two groups	—

Measure

Time frame

(1) HbA1c (NGSP) (2) Body weight, BMI (3) Waist circumference (4) ALP (BAP), TRACP5b (5) Muscle strength (6) Fasting plasma glucose level, HOMA-b, HOMA-R (7) Cholesterol level (TC, LDL-C, fasting TG, HDL-C) (8) Blood pressure (9) Adipocytokine (adiponectin), inflammatory marker (hs-CRP) (10) Subctaneus fat area, total fat area (11) Respiratory quotient, basal metabolism, whole body DXA, eating behavior questionnaire, calories and glucose amount (12) The change rate of the abdominal muscle area by CT after 24 weeks therapy in the two groups (13) The change rate of the bone density in the fourth lumbar vertebra by CT after 24 weeks therapy in the two groups

—

Countries

Japan

Contacts

Public ContactKou Ishikawa

Chiba University Department of Medicine, Division of Metabolism and Endocrinology

ishikawako@chiba-u.jp043-226-2089

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026