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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Peritoneal Dialysis
• Intervention / Treatment: Drug: Linagliptin; Drug: Humalog Mix 75/25

• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanbing Li, MD,PhD; Phone Number: +86-13925111691; Email: easd04lyb@126.com
• Study Contact Backup: Name: Xueqing Yu; Phone Number: +86-13802793488; Email: yuxq@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • endocrinology department of the first affiliated hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose variability	The change from baseline to week 12 in glucose variability indicated by MAGE.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes in HbA1c between two groups	12 weeks
FPG	Changes in FPG between two groups	12 weeks
insulin dosage	Changes in FPG at the end between two groups	12 weeks
body weight	Changes in body weight at the end between two groups	12 weeks
hypoglycemia	Frequency of hypoglycemia at the end in each gropu	12 weeks

Collaborators and Investigators

• Sponsor: Yanbing Li

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2017
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: peritoneal dialysis; glycemic variability; Linagliptin; premixedinsulin therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin; Insulin Lispro
• Other Study ID Numbers: 2017187

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No