The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01617434
First received: June 8, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.


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: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin A1c) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in 7-point self-measured plasma glucose from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below 7.0% (American Diabetes Association (ADA) target) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events (AE) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of subjects with severe hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 446
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide Drug: liraglutide
Max. 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
Placebo Comparator: Placebo Drug: placebo
Liraglutide placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
  • HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
  • Body mass index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
  • Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
  • Impaired liver or renal function
  • Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
  • Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
  • Known or suspected abuse of alcohol or narcotics
  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: NCT01617434

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Danville, California, United States, 94526
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93726
Novo Nordisk Clinical Trial Call Center
San Mateo, California, United States, 94401
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780-7045
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Greenfield, Indiana, United States, 46140
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Methuen, Massachusetts, United States, 01844
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Newington, New Hampshire, United States, 03801
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Upper St Clair, Pennsylvania, United States, 15241
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78215
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Midlothian, Virginia, United States, 23114
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23219
United States, Washington
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
United States, West Virginia
Novo Nordisk Clinical Trial Call Center
Martinsburg, West Virginia, United States, 25401
Argentina
Córdoba, Argentina, X5016KEH
Canada, Ontario
Smiths Falls, Ontario, Canada, K7A 4W8
Finland
Tampere, Finland, 33520
Germany
Berlin, Germany, 13055
India
Mumbai, Maharashtra, India, 400012
Mexico
Mexico, D.F., México, D.F., Mexico, 03800
Netherlands
Groningen, Netherlands, 9728 NT
Serbia
Nis, Serbia, 18000
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: NCT01617434     History of Changes
Other Study ID Numbers: NN2211-3917, 2011-002696-41, U1111-1121-9874
Study First Received: June 8, 2012
Last Updated: December 20, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health and Family Wellfare
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate
Serbia: Medicines and Medical Devices Agency of Serbia
Slovenia: Agency for Medicinal Products
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 26, 2014