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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03320031
• Other study ID #: 2017187
• Status: Recruiting
• Phase: Phase 4
• First received: October 20, 2017
• Last updated: October 20, 2017
• Start date: June 3, 2017
• Est. completion date: December 2019

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Yanbing Li, MD,PhD
• Phone: +86-13925111691
• Email: easd04lyb[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Peritoneal Dialysis
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Linagliptin
Take linagliptin 5mg a day.
• Humalog Mix 75/25
Administer subcutaneous premixed insulin twice a day.

Locations

Country	Name	City	State
China	endocrinology department of the first affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yanbing Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose variability	The change from baseline to week 12 in glucose variability indicated by MAGE.	12 weeks
Secondary	HbA1c	Changes in HbA1c between two groups	12 weeks
Secondary	FPG	Changes in FPG between two groups	12 weeks
Secondary	insulin dosage	Changes in FPG at the end between two groups	12 weeks
Secondary	body weight	Changes in body weight at the end between two groups	12 weeks
Secondary	hypoglycemia	Frequency of hypoglycemia at the end in each gropu	12 weeks