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

NCT03118713 | Terminated Phase 4

• 1 other identifier: 1941-MA-3122-KR
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Metformin; Ipragliflozin; Type 2 Diabetes Mellitus; ASP1941; Glimepiride

Outcome Measures

Primary Outcomes (1)

• The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR)

  Early morning urinary sample will be collected for the test

  Baseline up to 24 weeks

Secondary Outcomes (10)

• The percentage of patients whose UACR level is normalized or improved more than 50%

  Baseline up to 24 weeks

• Change from baseline in Estimated glomerular filtration rate (e-GFR)

  Baseline up to 24 weeks

• Change from baseline in Hemoglobin A1c (HbA1c)

  Baseline up to 24 weeks

• Change from baseline in Fasting Plasma Glucose (FPG)

  Baseline up to 24 weeks

• Change from baseline in body weight

  Baseline up to 24 weeks

Study Arms (2)

ipragliflozin and metformin

EXPERIMENTAL

Subjects will receive daily dosage of ipragliflozin and metformin as single tablets

Drug: metformin; Drug: ipragliflozin

glimepiride and metformin

EXPERIMENTAL

Subjects will receive daily dosage of glimepiride and metformin as single tablets

Drug: metformin; Drug: glimepiride

Interventions

metformin DRUG

oral

Also known as: Fortamet, Riomet, Glucophage, Diabex XR, Glumetza, Diabex, Glucophage XR

glimepiride and metformin; ipragliflozin and metformin

ipragliflozin DRUG

oral

Also known as: ASP1941, Suglat

ipragliflozin and metformin

glimepiride DRUG

oral

Also known as: Amaryl

glimepiride and metformin

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (8)

Site 13

Busan, South Korea

Location

Site 02

Deagu, South Korea

Location

Site 11

Guri-si, South Korea

Location

Site 01

Seoul, South Korea

Location

Site 05

Seoul, South Korea

Location

Site 07

Seoul, South Korea

Location

Site 09

Seoul, South Korea

Location

Site 12

Suwon, South Korea

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; ipragliflozin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Monitor

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: April 25, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)