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Liraglutide Treatment to Patients With Severe Renal Insufficiency

Primary Purpose

Type 2 Diabetes Mellitus, End-stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
Bo Feldt-Rasmussen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Liraglutide, Uremia, Dialysis, Type 2 diabetes mellitus, Safety, Efficacy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria - patients with T2D in dialysis

  • Male or female; aged 18-85 years
  • End-stage renal disease
  • Chronic dialysis treatment (minimum 3 months)
  • T2D (diagnosed according to WHO criteria)
  • Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
  • Documented beta cell function (evaluated by a glucagon test)

Inclusion criteria - patients with T2D and normal kidney function

  • Male or female; aged 18-85 years
  • Normal kidney function: Plasma creatinine <0.105 mmol/L for men and <0.090 mmol/L for women
  • T2D (diagnosed according to WHO criteria)
  • Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
  • Documented beta cell function (evaluated by a glucagon test)
  • Hemoglobin A1c ≥6.5%

Exclusion Criteria - both groups

  • Type 1 diabetes mellitus
  • Chronic pancreatitis / previous acute pancreatitis
  • Known or suspected hypersensitivity to trial product(s) or related products
  • Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
  • Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder which in the investigators' opinion could interfere with the results of the trial
  • Inflammatory bowel disease
  • Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
  • Body mass index ≤ 18.5 kg/m2 or ≥ 50.0 kg/m2
  • Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
  • Clinical signs of diabetic gastroparesis
  • Impaired liver function (transaminases >two times upper reference levels)
  • Receipt of any investigational product 90 days prior to this trial
  • Known or suspected abuse of alcohol or narcotics
  • Screening calcitonin ≥50 ng/l
  • Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Sites / Locations

  • Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet
  • Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
  • Department of Internal Medicine H, Hillerød Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

T2D, Dialysis, Liraglutide

T2D, Dialysis, Placebo

T2D, Normal kidney function, Liraglutide

T2D, Normal kidney function, Placebo

Arm Description

Daily liraglutide treatment Chronic dialysis treatment

Daily placebo Chronic dialysis treatment

Daily Liraglutide treatment Normal kidney function

Daily placebo treatment Normal kidney function

Outcomes

Primary Outcome Measures

Plasma liraglutide concentration (pmol/L)
Plasma liraglutide concentration evaluated over time during continuous intervention

Secondary Outcome Measures

Hypoglycaemia; minor or major
Number of hypoglycaemic episodes during intervention. Minor (blood glucose <3.1 mmol/L, no need for assistance). Major (blood glucose <3.1 mmol/L, assistance from third person required)
Glycaemic control
Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.
Pancreatic beta-cell function
Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.
Cardiovascular risk factors (lipids and blood pressure)
Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.

Full Information

First Posted
July 11, 2011
Last Updated
October 8, 2013
Sponsor
Bo Feldt-Rasmussen
Collaborators
Novo Nordisk A/S, The GCP unit at Copenhagen University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01394341
Brief Title
Liraglutide Treatment to Patients With Severe Renal Insufficiency
Official Title
Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Feldt-Rasmussen
Collaborators
Novo Nordisk A/S, The GCP unit at Copenhagen University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, End-stage Renal Disease
Keywords
Liraglutide, Uremia, Dialysis, Type 2 diabetes mellitus, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T2D, Dialysis, Liraglutide
Arm Type
Active Comparator
Arm Description
Daily liraglutide treatment Chronic dialysis treatment
Arm Title
T2D, Dialysis, Placebo
Arm Type
Placebo Comparator
Arm Description
Daily placebo Chronic dialysis treatment
Arm Title
T2D, Normal kidney function, Liraglutide
Arm Type
Active Comparator
Arm Description
Daily Liraglutide treatment Normal kidney function
Arm Title
T2D, Normal kidney function, Placebo
Arm Type
Placebo Comparator
Arm Description
Daily placebo treatment Normal kidney function
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
Daily sc. injection, individual dosage
Primary Outcome Measure Information:
Title
Plasma liraglutide concentration (pmol/L)
Description
Plasma liraglutide concentration evaluated over time during continuous intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hypoglycaemia; minor or major
Description
Number of hypoglycaemic episodes during intervention. Minor (blood glucose <3.1 mmol/L, no need for assistance). Major (blood glucose <3.1 mmol/L, assistance from third person required)
Time Frame
12 weeks
Title
Glycaemic control
Description
Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.
Time Frame
12 weeka
Title
Pancreatic beta-cell function
Description
Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.
Time Frame
12 weeks
Title
Cardiovascular risk factors (lipids and blood pressure)
Description
Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria - patients with T2D in dialysis Male or female; aged 18-85 years End-stage renal disease Chronic dialysis treatment (minimum 3 months) T2D (diagnosed according to WHO criteria) Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin Documented beta cell function (evaluated by a glucagon test) Inclusion criteria - patients with T2D and normal kidney function Male or female; aged 18-85 years Normal kidney function: Plasma creatinine <0.105 mmol/L for men and <0.090 mmol/L for women T2D (diagnosed according to WHO criteria) Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin Documented beta cell function (evaluated by a glucagon test) Hemoglobin A1c ≥6.5% Exclusion Criteria - both groups Type 1 diabetes mellitus Chronic pancreatitis / previous acute pancreatitis Known or suspected hypersensitivity to trial product(s) or related products Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder which in the investigators' opinion could interfere with the results of the trial Inflammatory bowel disease Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months Body mass index ≤ 18.5 kg/m2 or ≥ 50.0 kg/m2 Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods Clinical signs of diabetic gastroparesis Impaired liver function (transaminases >two times upper reference levels) Receipt of any investigational product 90 days prior to this trial Known or suspected abuse of alcohol or narcotics Screening calcitonin ≥50 ng/l Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Feldt-Rasmussen, Prof, DMSc
Organizational Affiliation
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Idorn, MD
Organizational Affiliation
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen Ø
State/Province
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen Ø
State/Province
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Internal Medicine H, Hillerød Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26283739
Citation
Idorn T, Knop FK, Jorgensen MB, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial. Diabetes Care. 2016 Feb;39(2):206-13. doi: 10.2337/dc15-1025. Epub 2015 Aug 17.
Results Reference
derived
PubMed Identifier
23624993
Citation
Idorn T, Knop FK, Jorgensen M, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study. BMJ Open. 2013 Apr 26;3(4):e002764. doi: 10.1136/bmjopen-2013-002764. Print 2013.
Results Reference
derived

Learn more about this trial

Liraglutide Treatment to Patients With Severe Renal Insufficiency

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