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MicroalbuminuriaPhase 4NCT02462369

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

A Phase 4 study testing Saxagliptin and glimepiride in people with Microalbuminuria and Microalbuminuria /Creatinine Ratios ACR, run by The Second Hospital of Nanjing Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 70 years
What is being tested?
Saxagliptin and glimepiride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
Jun 2015to Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

About this study

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

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).

Read the 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.

Being tested
Saxagliptin, glimepiride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaxagliptinDrug

  • glimepirideDrug

Study groups in NCT02462369
Study groupRoleWhat they receive
SaxagliptinExperimentalSaxagliptin 5mg/d, 52 weeks
Receives: Drug: Saxagliptin
glimepirideActive comparatorglimepiride 1~4mg/d,52 weeks
Receives: Drug: glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. microalbuminuria improvement in T2DM treated with saxagliptin

    Measured: 52 weeks

Secondary outcomes (1)

  1. incidence of hypoglycaemia of saxagliptin or glimepiride

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionApr 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462369
Sponsor's protocol ID
SecondNanjingMU
Status last verified
Apr 2015
First submitted
8 Apr 2015
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

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

  • 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.

    PubMed 16612330

  • 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.

    PubMed 20388897

  • 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.

    PubMed 21206136

  • 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.

    PubMed 22025647

  • 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.

    PubMed 24026560

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin and glimepiride in people with Microalbuminuria and Microalbuminuria /Creatinine Ratios ACR, run by The Second Hospital of Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

microalbuminuria improvement in T2DM treated with saxagliptin (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462369, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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