A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy

Sponsor

Yanbing Li (Other)

Overall Status

Unknown status

CT.gov ID

NCT03320031

Collaborator

(none)

232

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Peritoneal Dialysis	Drug: Linagliptin Drug: Humalog Mix 75/25	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 3, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: combined group Drug: linagliptin&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks.	Drug: Linagliptin Take linagliptin 5mg a day. Other Names: Trajenta Drug: Humalog Mix 75/25 Administer subcutaneous premixed insulin twice a day. Other Names: insulin lispro 75/25
Active Comparator: linsulin group Drug: premixed insulin Treated with premixed insulin for 12 weeks.	Drug: Humalog Mix 75/25 Administer subcutaneous premixed insulin twice a day. Other Names: insulin lispro 75/25

Arm

Intervention/Treatment

Experimental: combined group

Drug: linagliptin&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks.

Drug: Linagliptin

Take linagliptin 5mg a day.

Other Names:

Trajenta

Drug: Humalog Mix 75/25

Administer subcutaneous premixed insulin twice a day.

Other Names:

insulin lispro 75/25

Active Comparator: linsulin group

Drug: premixed insulin Treated with premixed insulin for 12 weeks.

Drug: Humalog Mix 75/25

Administer subcutaneous premixed insulin twice a day.

Other Names:

insulin lispro 75/25

Outcome Measures

Primary Outcome Measures

glucose variability [12 weeks]
The change from baseline to week 12 in glucose variability indicated by MAGE.

Secondary Outcome Measures

HbA1c [12 weeks]
Changes in HbA1c between two groups
FPG [12 weeks]
Changes in FPG between two groups
insulin dosage [12 weeks]
Changes in FPG at the end between two groups
body weight [12 weeks]
Changes in body weight at the end between two groups
hypoglycemia [12 weeks]
Frequency of hypoglycemia at the end in each gropu

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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