Type 2 Diabetes Mellitus
Conditions
Keywords
Ipragliflozin, Sitagliptin
Brief summary
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.
Detailed 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.
Interventions
DRUGIpragliflozin
Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
DRUGSitagliptin
Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
Sponsors
Astellas Pharma Korea, Inc.
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin | Baseline, week 12, week 24 | Change of HbA1c after 24 weeks' treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Baseline, week 12, week 24 | Change of body weight at week 24 |
| Body fat mass | Baseline, week 24 | Change of body fat mass at week 24 |
| Fasting plasma glucose level | Baseline, week 12, week 24 | Change of fasting plasma glucose level at week 24 |
| Postprandial 2hr glucose level | Baseline, week 12, week 24 | Changes of postprandial 2hr glucose level at week 24 |
| Glycemic target goal achievement | Baseline, week 12, week 24 | Glycemic target goal achievement (HbA1c \< 7%) at week 24 |
| Triglyceride/HDL-cholesterol ratio | Baseline, week 12, week 24 | Changes of triglyceride/HDL-cholesterol ratio at week 24 |
| Uric acid | Baseline, week 12, week 24 | Changes of uric acid at week 24 |
| Parathyroid hormone | Baseline, week 12, week 24 | Changes of parathyroid hormone at week 24 |
| 25-hydroxyvitamin D | Baseline, week 12, week 24 | Changes of 25-hydroxyvitamin D at week 24 |
| Blood Pressure | Baseline, week 12, week 24 | Change of systolic/diastolic blood pressure at week 24 |
Countries
South Korea
Outcome results
None listed