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

March 6, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9, France, 85295
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Pointe À Pitre, France, 97159
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67000
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-435
        • Novo Nordisk Investigational Site
      • Bialystok, Poland, 15-381
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-546
        • Novo Nordisk Investigational Site
      • Katowice, Poland, 40-767
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-261
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-569
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-111
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420043
        • Novo Nordisk Investigational Site
      • Kursk, Russian Federation, 305035
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123448
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 127411
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod, Russian Federation, 603126
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440026
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
      • Samara, Russian Federation, 443067
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410039
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410031
        • Novo Nordisk Investigational Site
      • Smolensk, Russian Federation, 214019
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400138
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61000
        • Novo Nordisk Investigational Site
      • Kiev, Ukraine, 04053
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk Investigational Site
      • Zaporizhia, Ukraine, 69600
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2RW
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Novo Nordisk Investigational Site
      • Letchworth, United Kingdom, SG6 4UB
        • Novo Nordisk Investigational Site
      • London, United Kingdom, E1 2EF
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE5 9RT
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Monterey, California, United States, 93940
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90502
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • Saint Petersburg, Florida, United States, 33711
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
      • Southfield, Michigan, United States, 48034-7661
        • Novo Nordisk Investigational Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New York
      • Rosedale, New York, United States, 11422
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Mooresville, North Carolina, United States, 28117
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
      • Wadsworth, Ohio, United States, 44281-9236
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • McMurray, Pennsylvania, United States, 15317
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37404-1192
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23298
        • Novo Nordisk Investigational Site
      • Winchester, Virginia, United States, 22601
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
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.
Experimental: Lira 1.8 mg
Drug: liraglutide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Time Frame: Week 0, Week 26
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Time Frame: At week 26
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
At week 26
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
Time Frame: At week 26
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.
At week 26
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
Time Frame: Week 0, week 26
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.
Week 0, week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Time Frame: Week 0, week 26
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
Week 0, week 26
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)
Time Frame: Week 0, week 26
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.
Week 0, week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2012

Primary Completion (Actual)

August 20, 2013

Study Completion (Actual)

August 20, 2013

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3916
  • 2011-002968-24 (EudraCT Number)
  • U1111-1122-3303 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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