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

NCT ID: NCT03320031

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-03
• Study Completion Date: 2019-12-31

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.

Conditions

Type 2 Diabetes Mellitus; Peritoneal Dialysis

Keywords

Linagliptin; premixedinsulin therapy; peritoneal dialysis; glycemic variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combined group

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

Group Type: EXPERIMENTAL

Linagliptin

Intervention Type: DRUG

Take linagliptin 5mg a day.

Humalog Mix 75/25

Intervention Type: DRUG

Administer subcutaneous premixed insulin twice a day.

linsulin group

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

Group Type: ACTIVE_COMPARATOR

Humalog Mix 75/25

Intervention Type: DRUG

Administer subcutaneous premixed insulin twice a day.

Interventions

Linagliptin

Take linagliptin 5mg a day.

Intervention Type: DRUG

Humalog Mix 75/25

Administer subcutaneous premixed insulin twice a day.

Intervention Type: DRUG

Other Intervention Names

Trajenta; insulin lispro 75/25

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanbing Li

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

Director of Endocrinology and Metabolism Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanbing Li, MD,PhD

Role: CONTACT

Phone: +86-13925111691

Email: easd04lyb@126.com

Xueqing Yu

Role: CONTACT

Phone: +86-13802793488

Email: yuxq@mail.sysu.edu.cn

Facility Contacts

Yanbing Li, MD,PhD

Role: primary

Other Identifiers

2017187

Identifier Type: -

Identifier Source: org_study_id