search
Back to results

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
  • HbA1c 7-10% (both inclusive)
  • Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
  • Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
  • Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
  • Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
  • Heart failure defined as New York Heart Association (NYHA) class IV
  • A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
  • Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
  • Use of immunosuppressive treatment within 90 days prior to screening
  • Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lira 1.8 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.

Secondary Outcome Measures

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.

Full Information

First Posted
June 13, 2012
Last Updated
March 6, 2019
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01620489
Brief Title
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Official Title
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2012 (Actual)
Primary Completion Date
August 20, 2013 (Actual)
Study Completion Date
August 20, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment. The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lira 1.8 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
Primary Outcome Measure Information:
Title
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Description
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
Time Frame
Week 0, Week 26
Secondary Outcome Measure Information:
Title
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Description
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
Time Frame
At week 26
Title
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
Description
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
Time Frame
At week 26
Title
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
Description
SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.
Time Frame
Week 0, week 26
Title
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Description
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
Time Frame
Week 0, week 26
Title
Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
Description
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.
Time Frame
Week 0, week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines HbA1c 7-10% (both inclusive) Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive) Exclusion Criteria: Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit History of chronic pancreatitis or idiopathic acute pancreatitis Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram)) Heart failure defined as New York Heart Association (NYHA) class IV A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator Use of immunosuppressive treatment within 90 days prior to screening Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461-4231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034-7661
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-6815
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281-9236
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-1192
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHE-sur-YON cedex 9
ZIP/Postal Code
85295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pointe À Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-381
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-767
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-261
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-111
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420043
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
123448
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127411
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410031
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Vinnytsia
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2RW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Letchworth
ZIP/Postal Code
SG6 4UB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
E1 2EF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE5 9RT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26681713
Citation
Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syren A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.
Results Reference
result
PubMed Identifier
30663196
Citation
Zobel EH, von Scholten BJ, Goldman B, Persson F, Hansen TW, Rossing P. Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment. Diabetes Obes Metab. 2019 May;21(5):1261-1265. doi: 10.1111/dom.13638. Epub 2019 Feb 22.
Results Reference
result
PubMed Identifier
29729957
Citation
Kim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

We'll reach out to this number within 24 hrs