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

October 1, 2022 updated by: Soo Lim, Seoul National University Bundang Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: Baseline, week 12, week 24
Change of HbA1c after 24 weeks' treatment
Baseline, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic target goal achievement
Time Frame: Baseline, week 12, week 24
Glycemic target goal achievement (HbA1c < 7%) at week 24
Baseline, week 12, week 24
Body weight
Time Frame: Baseline, week 12, week 24
Change of body weight at week 24
Baseline, week 12, week 24
Body fat mass
Time Frame: Baseline, week 24
Change of body fat mass at week 24
Baseline, week 24
Fasting plasma glucose level
Time Frame: Baseline, week 12, week 24
Change of fasting plasma glucose level at week 24
Baseline, week 12, week 24
Postprandial 2hr glucose level
Time Frame: Baseline, week 12, week 24
Changes of postprandial 2hr glucose level at week 24
Baseline, week 12, week 24
Blood Pressure
Time Frame: Baseline, week 12, week 24
Change of systolic/diastolic blood pressure at week 24
Baseline, week 12, week 24
Triglyceride/HDL-cholesterol ratio
Time Frame: Baseline, week 12, week 24
Changes of triglyceride/HDL-cholesterol ratio at week 24
Baseline, week 12, week 24
Uric acid
Time Frame: Baseline, week 12, week 24
Changes of uric acid at week 24
Baseline, week 12, week 24
Parathyroid hormone
Time Frame: Baseline, week 12, week 24
Changes of parathyroid hormone at week 24
Baseline, week 12, week 24
25-hydroxyvitamin D
Time Frame: Baseline, week 12, week 24
Changes of 25-hydroxyvitamin D at week 24
Baseline, week 12, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Astellas Pharma Korea, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2017

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1612/375-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Yes

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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