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Completed

NCT Number: NCT03076112

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ipragliflozin

Drug

Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

Other names: Suglat

Sitagliptin

Drug

Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

Other names: Januvia

Primary outcomes

  1. Glycated hemoglobin

    Time frame: Baseline, week 12, week 24

    Change of HbA1c after 24 weeks' treatment

Secondary outcomes

  1. Glycemic target goal achievement

    Time frame: Baseline, week 12, week 24

    Glycemic target goal achievement (HbA1c < 7%) at week 24

  2. Body weight

    Time frame: Baseline, week 12, week 24

    Change of body weight at week 24

  3. Body fat mass

    Time frame: Baseline, week 24

    Change of body fat mass at week 24

  4. Fasting plasma glucose level

    Time frame: Baseline, week 12, week 24

    Change of fasting plasma glucose level at week 24

  5. Postprandial 2hr glucose level

    Time frame: Baseline, week 12, week 24

    Changes of postprandial 2hr glucose level at week 24

  6. Blood Pressure

    Time frame: Baseline, week 12, week 24

    Change of systolic/diastolic blood pressure at week 24

  7. Triglyceride/HDL-cholesterol ratio

    Time frame: Baseline, week 12, week 24

    Changes of triglyceride/HDL-cholesterol ratio at week 24

  8. Uric acid

    Time frame: Baseline, week 12, week 24

    Changes of uric acid at week 24

  9. Parathyroid hormone

    Time frame: Baseline, week 12, week 24

    Changes of parathyroid hormone at week 24

  10. 25-hydroxyvitamin D

    Time frame: Baseline, week 12, week 24

    Changes of 25-hydroxyvitamin D at week 24

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2017
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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