Renal effects of Saxagliptin and Linagliptin in diabetic nephropathy: A randomized, double-blind, head to head study.

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15006340
• Date of registration: 2015-04-28
• Prospective Registration: Yes
• Primary sponsor: Tianjin Medical University
• Public title: Renal effects of Saxagliptin and Linagliptin in diabetic nephropathy: A randomized, double-blind, head to head study.
• Scientific title: Renal effects of Saxagliptin and Linagliptin in diabetic nephropathy: A randomized, double-blind, head to head study.
• Date of first enrolment: 2015-05-07
• Target sample size: Saxagliptin group:37;Linagliptin group:37;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10905
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Huimin Li
• Affiliation: Tianjin Medical University

• Name: Zhongming Wu

Key inclusion & exclusion criteria

Inclusion criteria: 1. Outpatients in line with diagnostic criteria for type 2 diabetes;
2. Urinary albumin/creatinine ratio (ACR) not less than 30 mg/g;
3. GFR not less than 60 ml/min;
4. Combined with diet, exercise and the current regimen, blood glucose is still poorly controlled.
Exclusion criteria: 1. Type 1 diabetes or secondary diabetes;
2. Gestational diabetes, lactational diabetes and diabetes planning to be pregnant;
3. Urinary tract infection or other serious infections;
4. With other non-diabetic kidney disease;
5. DPP-4 inhibitors or GLP-1 agonist medication history within a month;
6. Insulin medication history;
7. With resistant hypertension;
8. ACEI or ARB medication history;
9. Severe renal impairment (creatinine clearance<60 ml/min or serum creatinine>150 umol/L);
10. Severely impaired liver function (serum alanine aminotransferase or aspartate aminotransferase more than 3 times of the upper limit);
11. History of acute diabetic complications, history of trauma and history of surgery within the past month;
12. With any major psychiatric disorder;
13. Hypersusceptibility to the test medicine or with allergies;
14. Participating in other clinical trials;
15. Alcohol or psychoactive substance abusers and addicts;
16. According to the judgment of researchers, it will reduce the possibility to participate the study or make the participating more complex, for example, change the work or living environment frequently.

Age minimum: 35
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Nephropathy

Intervention(s)

Saxagliptin group:with Saxagliptin treatment;Linagliptin group:with Linagliptin treatment;

Primary Outcome(s)

Urinary albumin creatinine ratio;Transferrin;N- acetyl-Beta-D- glucosidase;Beta 2-microglobulin;

Secondary Outcome(s)

Weight;Blood pressure;Fasting blood glucose;Glycolated hemoglobin;Blood lipid;

Source(s) of Monetary Support

The National Natural Science General Program