Clincosm LogoSign in Get a demo

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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03076112
Collaborator
Astellas Pharma Korea, Inc. (Industry)
170
Enrollment
1
Location
2
Arms
62.2
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin
Actual Study Start Date :
Apr 25, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ipragliflozin

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

Drug: Ipragliflozin
Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
Other Names:
  • Suglat

    		•
    Active Comparator: Sitagliptin

    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

    Drug: Sitagliptin
    Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
    Other Names:
  • Januvia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glycated hemoglobin [Baseline, week 12, week 24]

      Change of HbA1c after 24 weeks' treatment

    Secondary Outcome Measures

    1. Glycemic target goal achievement [Baseline, week 12, week 24]

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

    2. Body weight [Baseline, week 12, week 24]

      Change of body weight at week 24

    3. Body fat mass [Baseline, week 24]

      Change of body fat mass at week 24

    4. Fasting plasma glucose level [Baseline, week 12, week 24]

      Change of fasting plasma glucose level at week 24

    5. Postprandial 2hr glucose level [Baseline, week 12, week 24]

      Changes of postprandial 2hr glucose level at week 24

    6. Blood Pressure [Baseline, week 12, week 24]

      Change of systolic/diastolic blood pressure at week 24

    7. Triglyceride/HDL-cholesterol ratio [Baseline, week 12, week 24]

      Changes of triglyceride/HDL-cholesterol ratio at week 24

    8. Uric acid [Baseline, week 12, week 24]

      Changes of uric acid at week 24

    9. Parathyroid hormone [Baseline, week 12, week 24]

      Changes of parathyroid hormone at week 24

    10. 25-hydroxyvitamin D [Baseline, week 12, week 24]

      Changes of 25-hydroxyvitamin D at week 24

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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 18mg or gliclazide 30120 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Gyeonggi Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital
    • Astellas Pharma Korea, Inc.

    Investigators

    • Principal Investigator: Soo Lim, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Soo Lim, Associate Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT03076112
    Other Study ID Numbers:
    • B-1612/375-004
    First Posted:
    Mar 9, 2017
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Soo Lim, Associate Professor, Seoul National University Bundang Hospital
    Ipragliflozin
    Sitagliptin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate
    Ipragliflozin

    Study Results

    No Results Posted as of Mar 30, 2021