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

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ClinicalTrials.gov Identifier: NCT03076112
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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
Type 2 Diabetes Mellitus Drug: Ipragliflozin Drug: Sitagliptin 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 25, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Januvia




Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: Baseline, week 12, week 24 ]
    Change of HbA1c after 24 weeks' treatment


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076112


Contacts
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Contact: Jie-Eun Lee, MD +82-10-7178-1569 orangerie@gmail.com
Contact: Soo Lim, MD, PhD +82-31-787-7035 limsoo@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Soo Lim, MD, PHD    82-31-787-7035    limsoo@snu.ac.kr   
Contact: Kyoung Min Kim, MD, PHD    82-31-787-7047    kyoungmin02@gmail.com   
Principal Investigator: Soo Lim, MD, PHD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Astellas Pharma Korea, Inc.
Investigators
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Principal Investigator: Soo Lim Seoul National University Bundang Hospital

Publications:

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Responsible Party: Soo Lim, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03076112     History of Changes
Other Study ID Numbers: B-1612/375-004
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Yes

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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, Seoul National University Bundang Hospital:
Ipragliflozin
Sitagliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Ipragliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors