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Trial record 7 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Peritoneal Dialysis"

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

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ClinicalTrials.gov Identifier: NCT03320031
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 3, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: Trajenta

Drug: Humalog Mix 75/25
Administer subcutaneous premixed insulin twice a day.
Other Name: 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 Name: insulin lispro 75/25




Primary Outcome Measures :
  1. glucose variability [ Time Frame: 12 weeks ]
    The change from baseline to week 12 in glucose variability indicated by MAGE.


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    Changes in HbA1c between two groups

  2. FPG [ Time Frame: 12 weeks ]
    Changes in FPG between two groups

  3. insulin dosage [ Time Frame: 12 weeks ]
    Changes in FPG at the end between two groups

  4. body weight [ Time Frame: 12 weeks ]
    Changes in body weight at the end between two groups

  5. hypoglycemia [ Time Frame: 12 weeks ]
    Frequency of hypoglycemia at the end in each gropu



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320031


Contacts
Contact: Yanbing Li, MD,PhD +86-13925111691 easd04lyb@126.com
Contact: Xueqing Yu +86-13802793488 yuxq@mail.sysu.edu.cn

Locations
China, Guangdong
endocrinology department of the first affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yanbing Li, MD,PhD    8602087334331    easd04lyb@126.com   
Principal Investigator: Yanbing Li, MD,PhD         
Sponsors and Collaborators
Yanbing Li

Responsible Party: Yanbing Li, Director of Endocrinology and Metabolism Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03320031     History of Changes
Other Study ID Numbers: 2017187
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanbing Li, Sun Yat-sen University:
Linagliptin
premixedinsulin therapy
peritoneal dialysis
glycemic variability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Linagliptin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action