Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Ipragliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03076112

B-1612/375-004

Details and patient eligibility

About

The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition including fat and muscle mass with volume status.

Full description

The objectives of this study are to compare the effect of 50mg of ipragliflozin, a SGLT2 inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a DPP4 inhibitor in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin.

We are also going to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers.

Changes of body composition including fat and muscle mass with volume status will be also examined.

Enrollment: 170 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes with HbA1c 7.5% - 9.0% at screening visit
• Male or female between 20 and 75 years of age
• Patients taking sulfonylurea (glimepiride 1~8mg or gliclazide 30~120 mg or equivalent dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
• BMI ≥23 kg/m²
• Estimated GFR ≥ 60 ml/min/1.73m²
• Women of child bearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must have a negative urinary pregnancy test.

Exclusion criteria

• Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
• Patients with acute coronary syndrome within 3 months prior to screening visit
• Patients with acute coronary syndrome within 3 months prior to screening visit
• Pregnant or breastfeeding women or reproductive-age women who refuse contraception
• Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
• Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
• Other clinical trials within 30 days
• Alcohol abuse
• Contraindication to SGLT2 inhibitors or Dipeptidyl-peptidase 4 inhibitors
• Taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Ipragliflozin

Experimental group

Description:

Ipragliflozin 50 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages Metformin 500 mg - 2550 mg Sulfonylurea: Glimepiride 1 mg - 8 mg or Gliclazide MR 30 mg - 120 mg

Treatment:

Drug: Ipragliflozin

Sitagliptin

Active Comparator group

Description:

Sitagliptin 100 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages Metformin 500 mg - 2550 mg Sulfonylurea: Glimepiride 1 mg - 8 mg or Gliclazide MR 30 mg - 120 mg

Treatment:

Drug: Sitagliptin