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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620489
First Posted: June 15, 2012
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

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.


Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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) [ 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 279
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01620489


  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
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
United States, Colorado
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
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
St. Petersburg, Florida, United States, 33711
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30303
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Indiana
Novo Nordisk Investigational Site
Avon, Indiana, United States, 46123
Novo Nordisk Investigational Site
Franklin, Indiana, United States, 46131-9121
Novo Nordisk Investigational Site
Greenfield, Indiana, United States, 46140
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Louisiana
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Springfield, Massachusetts, United States, 01199
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034-7661
United States, Montana
Novo Nordisk Investigational Site
Great Falls, Montana, United States, 59405
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New York
Novo Nordisk Investigational Site
Rosedale, New York, United States, 11422
Novo Nordisk Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Mooresville, North Carolina, United States, 28117
United States, Ohio
Novo Nordisk Investigational Site
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
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
McMurray, Pennsylvania, United States, 15317
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Novo Nordisk Investigational Site
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404-1192
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Amarillo, Texas, United States, 79106
Novo Nordisk Investigational Site
Lubbock, Texas, United States, 79423
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77479
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23294
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23298
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
France
Novo Nordisk Investigational Site
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
Poland
Novo Nordisk Investigational Site
Bialystok, Poland, 15-381
Novo Nordisk Investigational Site
Bialystok, Poland, 15-435
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, 60-111
Novo Nordisk Investigational Site
Poznan, Poland, 60-569
Novo Nordisk Investigational Site
Zabrze, Poland, 41-800
Russian Federation
Novo Nordisk Investigational Site
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, 194358
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 195257
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199034
Novo Nordisk Investigational Site
Samara, Russian Federation, 443067
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410012
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410039
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410053
Novo Nordisk Investigational Site
Smolensk, Russian Federation, 214019
Novo Nordisk Investigational Site
Volgograd, Russian Federation, 400138
Ukraine
Novo Nordisk Investigational Site
Kharkiv, Ukraine, 61000
Novo Nordisk Investigational Site
Kiev, Ukraine, 04053
Novo Nordisk Investigational Site
Kiev, Ukraine, 04114
Novo Nordisk Investigational Site
Vinnitsa, Ukraine, 21010
Novo Nordisk Investigational Site
Zaporozhye, Ukraine, 69600
United Kingdom
Novo Nordisk Investigational Site
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 2JZ
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620489     History of Changes
Other Study ID Numbers: NN2211-3916
2011-002968-24 ( EudraCT Number )
U1111-1122-3303 ( Other Identifier: WHO )
First Submitted: June 13, 2012
First Posted: June 15, 2012
Results First Submitted: August 20, 2014
Results First Posted: October 30, 2014
Last Update Posted: March 8, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists