Clinical trial NCT03320031: A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Peritoneal Dialysis
Keywords: Linagliptin
premixedinsulin therapy
peritoneal dialysis
glycemic variability
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetic patients who were treated with insulin regimen;
2. Ages eligible for study:18 years to 80 years;
3. The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;
4. HbA1c ranging from 6.5%-10.5% when screening and randomizing ;
5. Body mass index ranging from 21 to 35 kg/m2.

Exclusion Criteria:

1. Having any severe acute or chronic diabetic complications
2. Blood aminotransferase level rising up more than 2 times of the upper normal limit
3. Any severe cardiac disease, severe systemic diseases or malignant tumour
4. Female patients incline to be pregnant
5. Being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
6. Poor compliance

Primary outcomes:
measure: glucose variability
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: FPG
timeFrame: 12 weeks
measure: insulin dosage
timeFrame: 12 weeks
measure: body weight
timeFrame: 12 weeks
measure: hypoglycemia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: