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Saxagliptin's Effects on Microalbuminuria Improvement in Type 2 Diabetic Patients

Primary Purpose

Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Saxagliptin
glimepiride
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microalbuminuria

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Diagnosed with type 2 diabetes with stable, doses of metformin (1000mg~2550mg/d) or acarbose (100mg~300mg/d) at least 60 days
  3. Men and women (non-pregnant and using a medically approved birth-control method) aged at age ≥20 and ≤70 years at screening
  4. HbA1c ≥ 7.0% and ≤ 9.0% at screening
  5. 24-hour urinary albumin level of 30-300 mg/24 h

Exclusion Criteria:

1.Women, who are pregnant, or intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.

2. Diagnosis or history of:

  • Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, e.g acromegaly or Cushing's syndrome.
  • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.

    3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past 6 months. 4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4), glimepiride, metformin or acarbose.

    5. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months.

    6. Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening.

    7. Patients with clinically apparent liver disease characterized by either one of the following:

  • alanine aminotransferase((ALT) or aspartate aminotransferase(AST) > 3x upper limit of normal (ULN) confirmed on two consecutive measurements within 4 weeks prior to screening period
  • Impaired excretory (eg, hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices.
  • Acute viral or active autoimmune, alcoholic, or other types of hepatitis.

    8. Patients with moderate /severe renal impairment or end-stage renal disease (CrCl ≤ 50 mL/min) at screening or within 4 weeks prior to screening

    9. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV.

    10. Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.

    11. History of chronic pancreatitis or idiopathic acute pancreatitis.

    12. History of gastrointestinal disease including gastroenterostomy, enterectomy, severe hernia, intestinal obstruction, intestinal ulcer.

    13. History of medullary thyroid carcinoma.

    14. History of alcohol abuse or illegal drug abuse within the past 12 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Saxagliptin

    glimepiride

    Arm Description

    Saxagliptin 5mg/d, 52 weeks

    glimepiride 1~4mg/d,52 weeks

    Outcomes

    Primary Outcome Measures

    microalbuminuria improvement in T2DM treated with saxagliptin

    Secondary Outcome Measures

    incidence of hypoglycaemia of saxagliptin or glimepiride

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    July 27, 2015
    Sponsor
    The Second Hospital of Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02462369
    Brief Title
    Saxagliptin's Effects on Microalbuminuria Improvement in Type 2 Diabetic Patients
    Official Title
    The Effects of Saxagliptin 5mg, Once Daily for 52 Weeks on 24 Hour Urine Albumin Creatinine Rate(ACR) , in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin or/and Acarbose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Second Hospital of Nanjing Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compare the effects on microalbuminuria improvement in type 2 diabetes mellitus (T2DM) treated with saxagliptin or glimepiride.All patients received metformin and/or acarbose, and randomly receive saxagliptin (5mg/d) or glimepiride (1-4mg/d).
    Detailed Description
    Both sitagliptin and glimepiride are hypoglycemic agents,but they do so by different mechanisms.sitagliptin can delay degradation of glucagon-like peptide -1 (GLP-1) by inhibit DPPIV to decrease serum glucose level.glimepiride stimulates islets B cell to secrete insulin to decrease serum glucose level. Preclinical studies and several clinical trials (including vildagliptin, sitagliptin, linagliptin, exenatide) suggested that DPP-4i/GLP-1 might have a potential to lower albuminuria, albumin-creatinine ratio (ACR) or improve glomerular filtration rate(GFR) and the effect might be independent of changes in glucose control. Recently, SAVOR outcomes also showed that saxagliptin might have nephroprotective effects, and the proportion of patients with microalbuminuria converted into normal albuminuria after saxagliptin treatment for 1 year is 31.3%, but the mechanism is still unclear.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Saxagliptin
    Arm Type
    Experimental
    Arm Description
    Saxagliptin 5mg/d, 52 weeks
    Arm Title
    glimepiride
    Arm Type
    Active Comparator
    Arm Description
    glimepiride 1~4mg/d,52 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Saxagliptin
    Intervention Type
    Drug
    Intervention Name(s)
    glimepiride
    Primary Outcome Measure Information:
    Title
    microalbuminuria improvement in T2DM treated with saxagliptin
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    incidence of hypoglycaemia of saxagliptin or glimepiride
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes with stable, doses of metformin (1000mg~2550mg/d) or acarbose (100mg~300mg/d) at least 60 days Men and women (non-pregnant and using a medically approved birth-control method) aged at age ≥20 and ≤70 years at screening HbA1c ≥ 7.0% and ≤ 9.0% at screening 24-hour urinary albumin level of 30-300 mg/24 h Exclusion Criteria: 1.Women, who are pregnant, or intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods. 2. Diagnosis or history of: Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, e.g acromegaly or Cushing's syndrome. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months. 3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past 6 months. 4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4), glimepiride, metformin or acarbose. 5. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months. 6. Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening. 7. Patients with clinically apparent liver disease characterized by either one of the following: alanine aminotransferase((ALT) or aspartate aminotransferase(AST) > 3x upper limit of normal (ULN) confirmed on two consecutive measurements within 4 weeks prior to screening period Impaired excretory (eg, hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices. Acute viral or active autoimmune, alcoholic, or other types of hepatitis. 8. Patients with moderate /severe renal impairment or end-stage renal disease (CrCl ≤ 50 mL/min) at screening or within 4 weeks prior to screening 9. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV. 10. Significant cardiovascular history within the past 3 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident. 11. History of chronic pancreatitis or idiopathic acute pancreatitis. 12. History of gastrointestinal disease including gastroenterostomy, enterectomy, severe hernia, intestinal obstruction, intestinal ulcer. 13. History of medullary thyroid carcinoma. 14. History of alcohol abuse or illegal drug abuse within the past 12 months.

    12. IPD Sharing Statement

    Citations:
    Citation
    Mosenzon O, Bhatt DL, Likwat L, et al. Effect of saxagliptin on renal outcomes. 2014 ADA poster. 544-P.
    Results Reference
    background
    PubMed Identifier
    16612330
    Citation
    Parving HH, Lewis JB, Ravid M, Remuzzi G, Hunsicker LG; DEMAND investigators. Prevalence and risk factors for microalbuminuria in a referred cohort of type II diabetic patients: a global perspective. Kidney Int. 2006 Jun;69(11):2057-63. doi: 10.1038/sj.ki.5000377.
    Results Reference
    result
    PubMed Identifier
    20388897
    Citation
    Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010 Apr 14;303(14):1410-8. doi: 10.1001/jama.2010.405.
    Results Reference
    result
    PubMed Identifier
    21206136
    Citation
    Hattori S. Sitagliptin reduces albuminuria in patients with type 2 diabetes. Endocr J. 2011;58(1):69-73. doi: 10.1507/endocrj.k10e-382. Epub 2010 Dec 28.
    Results Reference
    result
    PubMed Identifier
    22025647
    Citation
    Liu WJ, Xie SH, Liu YN, Kim W, Jin HY, Park SK, Shao YM, Park TS. Dipeptidyl peptidase IV inhibitor attenuates kidney injury in streptozotocin-induced diabetic rats. J Pharmacol Exp Ther. 2012 Feb;340(2):248-55. doi: 10.1124/jpet.111.186866. Epub 2011 Oct 24.
    Results Reference
    result
    PubMed Identifier
    24026560
    Citation
    Groop PH, Cooper ME, Perkovic V, Emser A, Woerle HJ, von Eynatten M. Linagliptin lowers albuminuria on top of recommended standard treatment in patients with type 2 diabetes and renal dysfunction. Diabetes Care. 2013 Nov;36(11):3460-8. doi: 10.2337/dc13-0323. Epub 2013 Sep 11.
    Results Reference
    result

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    Saxagliptin's Effects on Microalbuminuria Improvement in Type 2 Diabetic Patients

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