Status:
UNKNOWN
A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
Lead Sponsor:
Yanbing Li
Conditions:
Type 2 Diabetes Mellitus
Peritoneal Dialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
In china, there are the most population of type 2 diabetes mellitus (DM) among the world and DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of insulin-treated PD ...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients who were treated with insulin regimen;
- Ages eligible for study:18 years to 80 years;
- The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;
- HbA1c ranging from 6.5%-10.5% when screening and randomizing ;
- Body mass index ranging from 21 to 35 kg/m2.
Exclusion
- Having any severe acute or chronic diabetic complications
- Blood aminotransferase level rising up more than 2 times of the upper normal limit
- Any severe cardiac disease, severe systemic diseases or malignant tumour
- Female patients incline to be pregnant
- Being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- Poor compliance
Key Trial Info
Start Date :
June 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT03320031
Start Date
June 3 2017
End Date
December 1 2019
Last Update
October 24 2017
Active Locations (1)
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1
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080