A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
A Randomized, Open, Controlled, Parallel Group Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
1 other identifier
interventional
232
1 country
1
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 patients in clinical practice are treated with premixed insulin. Glycemic control in them is very difficult to be achieved mainly due to the uremic status of these patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily non-renal elimination route, and does not require dose adjustment for any level of impaired renal function. The aim of this study is to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy. This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in China. After a 4-week run- in period, 232 participants are randomized (1:1) to either premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG, PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage, hypoglycemia and body weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Jun 2017
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2017
CompletedFirst Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 24, 2017
October 1, 2017
2.5 years
October 20, 2017
October 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glucose variability
The change from baseline to week 12 in glucose variability indicated by MAGE.
12 weeks
Secondary Outcomes (5)
HbA1c
12 weeks
FPG
12 weeks
insulin dosage
12 weeks
body weight
12 weeks
hypoglycemia
12 weeks
Study Arms (2)
combined group
EXPERIMENTALDrug: linagliptin\&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks.
linsulin group
ACTIVE COMPARATORDrug: premixed insulin Treated with premixed insulin for 12 weeks.
Interventions
Administer subcutaneous premixed insulin twice a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanbing Lilead
Study Sites (1)
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Endocrinology and Metabolism Department
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 24, 2017
Study Start
June 3, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 24, 2017
Record last verified: 2017-10