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A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

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ClinicalTrials.gov Identifier: NCT03118713
Recruitment Status : Terminated (Business decision due to enrollment challenges)
First Posted : April 18, 2017
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Brief Summary:
The primary purpose of this study is to assess the renal protective effect of ipragliflozin in combination with metformin on the percent change of UACR from baseline to 24 weeks against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: metformin Drug: ipragliflozin Drug: glimepiride Phase 4

Detailed Description:

This is a multicenter study that will compare ipragliflozin/metformin with glimepiride/metformin in the treatment of type 2 diabetes mellitus (T2DM) with albuminuria.

The study will include screening and 24-week treatment period. Subjects entering the study have been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1. For randomization, subject will be stratified by the site and the administration of renin-angiotensin system inhibitors (angiotensin receptor blockers and/or angiotensin-converting-enzyme inhibitors) at Visit 2. Subjects will be centrally randomized to either ipragliflozin/metformin group or glimepiride/metformin group and receive 24-week treatment by each group

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Renal Protective Effect (UACR), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ipragliflozin and metformin
Subjects will receive daily dosage of ipragliflozin and metformin as single tablets
Drug: metformin
oral
Other Names:
  • Fortamet
  • Riomet
  • Glucophage
  • Diabex XR
  • Glumetza
  • Diabex
  • Glucophage XR

Drug: ipragliflozin
oral
Other Names:
  • ASP1941
  • Suglat

Experimental: glimepiride and metformin
Subjects will receive daily dosage of glimepiride and metformin as single tablets
Drug: metformin
oral
Other Names:
  • Fortamet
  • Riomet
  • Glucophage
  • Diabex XR
  • Glumetza
  • Diabex
  • Glucophage XR

Drug: glimepiride
oral
Other Name: Amaryl




Primary Outcome Measures :
  1. The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR) [ Time Frame: Baseline up to 24 weeks ]
    Early morning urinary sample will be collected for the test


Secondary Outcome Measures :
  1. The percentage of patients whose UACR level is normalized or improved more than 50% [ Time Frame: Baseline up to 24 weeks ]
    Early morning urinary sample will be collected for the test

  2. Change from baseline in Estimated glomerular filtration rate (e-GFR) [ Time Frame: Baseline up to 24 weeks ]
    Test parameter e-GFR shall be measured at the local laboratory

  3. Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline up to 24 weeks ]
    Test parameter HbA1c shall be measured at the local laboratory

  4. Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline up to 24 weeks ]
    Test parameter FPG shall be measured at the local laboratory

  5. Change from baseline in body weight [ Time Frame: Baseline up to 24 weeks ]
    Body Weight shall be measured by the same scale for the clinical trial period

  6. Change from baseline in blood pressure [ Time Frame: Baseline up to 24 weeks ]
    Blood pressure will be measured two times with 1-2 minutes interval by the same arm and procedure during the study

  7. Change from baseline in Uric Acid [ Time Frame: Baseline up to 24 weeks ]
    Test parameter Uric Acid shall be measured at the local laboratory

  8. Change from baseline in health status as measured through EuroQol 5 Dimension 5 Level Health State Utility Index (EQ-5D-5L) questionnaire [ Time Frame: Baseline up to 24 weeks ]
    The EQ-5D-5L Questionnaire consists of 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression

  9. Change from baseline in health status as measured through EuroQol-Visual Analogue Scale (EQ VAS) questionnaire [ Time Frame: Baseline up to 24 weeks ]
    The EQ VAS measures the score (0 to 100) of change from baseline to 24 weeks

  10. Change from baseline in Quality of Life as measured through Audit of Diabetes-Dependent Quality of Life-19 (ADDQoL-19) questionnaire [ Time Frame: Baseline up to 24 weeks ]
    Quality of Life will be assessed through ADDQoL-19. Patients will be asked to complete the questionnaires at visit 2 and 5



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria assessed at Visit 1:

  • Subject who is outpatient.
  • Subject who has been diagnosed with type 2 diabetes mellitus.
  • Subject who has been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1.
  • Subject who has an HbA1C value between 7.0% and 9.0% at Visit 1.
  • Subject who has a urinary albumin/creatinine ratio greater than or equal to 30 mg/g at Visit 1.
  • Subject who has eGFR greater than or equal to 45 mL/min/1.73 m^2.
  • Subject is on stable diet and exercise program for at least 8 weeks (56 days) prior to Visit 1.

Inclusion Criterion assessed at Visit 2:

  • Subject who has a urinary albumin/creatinine ratio greater than or equal to 30 mg/g at Visit 2.

Exclusion Criteria:

  • Subject who has been diagnosed with type 1 diabetes mellitus.
  • Subject who started or has changed the types and/or dosage of Renin Angiotensin System (RAS) inhibitors (Angiotensin II Receptor Blockers (ARBs), ACE inhibitors) within 12 weeks prior to Visit 1.
  • Subject who has been treated with Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors within 12 weeks prior to Visit 1.
  • Subject who has a history of clinically significant renal disease(s) (other than diabetic nephropathy) such as renovascular occlusive disease, nephrectomy, or renal transplant.
  • Subject who has a diabetic ketoacidosis, or history of diabetic ketoacidosis.
  • Subject with diabetic coma or precoma.
  • Subject with severe infection, serious trauma, or perioperative subject at Visit 1
  • Subject who has a history of hypersensitivity to ipragliflozin or glimepiride or other SGLT-2 inhibitors or sulfonylureas.
  • Subject has Aspartate Aminotransferase (GOT) (AST) or Alanine Aminotransferase (GPT) (ALT) value exceeding 3 times of upper limit of the normal range, or total bilirubin value exceeding 3 times of upper limit of the normal range at Visit 1.
  • Subject has progressive proliferative diabetic retinopathy.
  • Subject has a symptomatic urinary tract infection or genital infection at Visit 1.
  • Subject has uncontrollable psychiatric disorder(s) with medication.
  • Subject abuses drug or alcohol at Visit 1.
  • Subject has lactic acidosis or has history of lactic acidosis.
  • Subject who has been known to have Hepatitis B, Hepatitis C or Positive Human immunodeficiency virus (HIV).
  • Subject is unable or unwilling to adhere to any of the protocol requirements such as hospital visits and dose instruction specified in this study.
  • Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • Subject has participated in another interventional study with study drugs within 12 weeks prior to obtaining written informed consent.
  • Subject has a clinical condition which would not allow safe conduct of the study.

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): NCT03118713


Locations
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Korea, Republic of
Site 13
Busan, Korea, Republic of
Site 02
Deagu, Korea, Republic of
Site 11
Guri-si, Korea, Republic of
Site 01
Seoul, Korea, Republic of
Site 05
Seoul, Korea, Republic of
Site 07
Seoul, Korea, Republic of
Site 09
Seoul, Korea, Republic of
Site 12
Suwon-si, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
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Study Director: Medical Monitor Astellas Pharma Korea, Inc.
Additional Information:
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Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT03118713    
Other Study ID Numbers: 1941-MA-3122-KR
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Metformin
Ipragliflozin
Type 2 Diabetes Mellitus
ASP1941
Glimepiride
Additional relevant MeSH terms:
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Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Metformin
Glimepiride
Ipragliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action