Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620489
First received: June 13, 2012
Last updated: October 23, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620489

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Monterey, California, United States, 93940
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92111
Novo Nordisk Clinical Trial Call Center
San Ramon, California, United States, 94583
Novo Nordisk Clinical Trial Call Center
Torrance, California, United States, 90502
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
Novo Nordisk Clinical Trial Call Center
Ventura, California, United States, 93003-2824
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Clinical Trial Call Center
Boynton Beach, Florida, United States, 33472
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33156
Novo Nordisk Clinical Trial Call Center
Pembroke Pines, Florida, United States, 33027
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
Novo Nordisk Clinical Trial Call Center
St. Petersburg, Florida, United States, 33711
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30303
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Avon, Indiana, United States, 46123-7877
Novo Nordisk Clinical Trial Call Center
Franklin, Indiana, United States, 46131-9121
Novo Nordisk Clinical Trial Call Center
Greenfield, Indiana, United States, 46140
Novo Nordisk Clinical Trial Call Center
Muncie, Indiana, United States, 47304
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Buckley, Michigan, United States, 49620
Novo Nordisk Clinical Trial Call Center
Southfield, Michigan, United States, 48034-7661
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States, 03063
United States, New York
Novo Nordisk Clinical Trial Call Center
Rosedale, New York, United States, 11422
Novo Nordisk Clinical Trial Call Center
Staten Island, New York, United States, 10301-3901
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27834
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Franklin, Ohio, United States, 45005
Novo Nordisk Clinical Trial Call Center
Mason, Ohio, United States, 45040-6815
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
McMurray, Pennsylvania, United States, 15317
Novo Nordisk Clinical Trial Call Center
Norristown, Pennsylvania, United States, 19401
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Novo Nordisk Clinical Trial Call Center
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Amarillo, Texas, United States, 79106
Novo Nordisk Clinical Trial Call Center
Lubbock, Texas, United States, 79423
Novo Nordisk Clinical Trial Call Center
Sugar Land, Texas, United States, 77479
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23219
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23294
Novo Nordisk Clinical Trial Call Center
Winchester, Virginia, United States, 22601
France
LA ROCHE-sur-YON cedex 9, France, 85295
Poland
Bialystok, Poland, 15-435
Russian Federation
Samara, Russian Federation, 443067
Ukraine
Kiev, Ukraine, 04114
United Kingdom
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620489     History of Changes
Other Study ID Numbers: NN2211-3916, 2011-002968-24, U1111-1122-3303
Study First Received: June 13, 2012
Results First Received: August 20, 2014
Last Updated: October 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Ministry of Health and Social Security
Russia: Federal Service for Control of Health Care and Social Development
Ukraine: Ministry of Health Ukraine
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014