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Protection of xagliptin tablets to pancreatic function on new diagnosed type 2 diabetes with csii

Protection of xagliptin tablets to pancreatic function on new diagnosed type 2 diabetes with csii

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-PPR-15007045
Enrollment
Unknown
Registered
2015-09-07
Start date
2015-09-09
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

A:Isulin pump
B:xagliptin

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. voluntary to attend this study signed the informed consent, comply with the requirements of this study; 2. between 18 75 years of age; 3. according to the who standards, the subjects should be diagnosed as type 2 diabetes; 4. the subjects agreed to maintain the original diet exercise habits throughout the study period; 5. the weight was stable during the last 12 weeks before the screening, weight change range (+ / - 5%); 6. fasting serum c-peptide>=1 ng/ml (333 pmol/l or higher).

Exclusion criteria

Exclusion criteria: 1. the probabl basic diseases which may obstruct this study,such as active malignancy, cardiomyopathy, cirrhosis or chronic lung disease; 2. using incretin therapy now or during the past 6 months,such as dpp-4 glp-1; 3. pregnancy, breast-feeding,or not using enough contraception(enough refers to the intrauterine device, oral contraceptives, prevent measures). 4.the history of human immunodeficiency virus (hiv). 5.severe autoimmune diseases such as lupus. 6.using the intravenous hormone therapy. 7.patiens accepted other drugs during the past 1 month. 8.impaired liver function,the alt is 2.5 times of theper limit. 9.start long-term dialysis and/or renal transplantation, and/or serum creatinine is 1.3 times greater than that of theper limit. 10.a history of drug abuse alcohol dependence in the past 5 years. 11.recurrent hypoglycemic events. 12.acute vascular events (heart or stroke)during the past two months before randomization. heart disease: decompented heart failure (type nyha ? ?), unstable angina, a heart attack in the past 12 months. 13.allergic to the drugs or related products (insulin, metal),or local induration in insulin injection site. 14.poor adherence.

Design outcomes

Primary

MeasureTime frame
function of islet beta cell;

Secondary

MeasureTime frame
Glucagon;free fatty acid;8-iso-PGF2 alpha;TNF-alpha;GLP-1;glucose fluctuation;

Countries

China

Contacts

Public ContactJianhua Ma
majianhua@china.com+86 025-86621776

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026