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

NCT02462369 | Unknown Phase 4

• 1 other identifier: SecondNanjingMU
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Microalbuminuria; Microalbuminuria /Creatinine Ratios ACR

Outcome Measures

Primary Outcomes (1)

• microalbuminuria improvement in T2DM treated with saxagliptin

  52 weeks

Secondary Outcomes (1)

• incidence of hypoglycaemia of saxagliptin or glimepiride

  52 weeks

Study Arms (2)

Saxagliptin

EXPERIMENTAL

Saxagliptin 5mg/d, 52 weeks

Drug: Saxagliptin

glimepiride

ACTIVE COMPARATOR

glimepiride 1\~4mg/d,52 weeks

Drug: glimepiride

Interventions

Saxagliptin DRUG

Saxagliptin

glimepiride DRUG

glimepiride

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hour urinary albumin level of 30-300 mg/24 h

You may not qualify if:

• ．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.
• \. 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.
• \. 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.
• \. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months.
• \. Triglycerides (fasting) \> 4.5 mmol/L (\> 400 mg/dL) at screening or within 4 weeks prior to screening.
• \. 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.
• \. Patients with moderate /severe renal impairment or end-stage renal disease (CrCl ≤ 50 mL/min) at screening or within 4 weeks prior to screening
• \. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV.
• \. 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.
• \. History of chronic pancreatitis or idiopathic acute pancreatitis.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Related Publications (6)

• Mosenzon O, Bhatt DL, Likwat L, et al. Effect of saxagliptin on renal outcomes. 2014 ADA poster. 544-P.

  BACKGROUND

• 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.

  PMID: 16612330 RESULT

• 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.

  PMID: 20388897 RESULT

• 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.

  PMID: 21206136 RESULT

• 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.

  PMID: 22025647 RESULT

• 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.

  PMID: 24026560 RESULT

MeSH Terms

Interventions

saxagliptin; glimepiride

Study Design

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

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 28, 2015

Record last verified: 2015-04