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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: January 25, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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 Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change from baseline in HbA1c after 26 weeks of treatment.


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change from baseline in FPG after 26 weeks of treatment.

  • Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.

  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ]
    The estimated mean change in body weight after 26 weeks of treatment.

  • Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target) [ Time Frame: At Week 26 ]
    Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment

  • Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target) [ Time Frame: At Week 26 ]
    Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.

  • Number of Adverse Events (AEs) During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.

  • Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).

  • Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.


Enrollment: 451
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
Maximum 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
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   (Adult, Senior)
Sexes Eligible for Study:   All
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, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85020
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Fresno, California, United States, 93726
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
San Mateo, California, United States, 94401
Novo Nordisk Investigational Site
San Ramon, California, United States, 94583
Novo Nordisk Investigational Site
Tustin, California, United States, 92780-7045
Novo Nordisk Investigational Site
Ventura, California, United States, 93003
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
United States, Illinois
Novo Nordisk Investigational Site
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Investigational Site
Greenfield, Indiana, United States, 46140
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Methuen, Massachusetts, United States, 01844
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Novo Nordisk Investigational Site
Newington, New Hampshire, United States, 03801
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27401-1023
United States, Pennsylvania
Novo Nordisk Investigational Site
McMurray, Pennsylvania, United States, 15317
United States, South Carolina
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
Novo Nordisk Investigational Site
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Midlothian, Virginia, United States, 23114
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
United States, West Virginia
Novo Nordisk Investigational Site
Martinsburg, West Virginia, United States, 25401
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425AGC
Novo Nordisk Investigational Site
Caba, Argentina, C1179AAB
Novo Nordisk Investigational Site
Caba, Argentina, C1180AAX
Novo Nordisk Investigational Site
Córdoba, Argentina, X5016KEH
Canada, British Columbia
Novo Nordisk Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Novo Nordisk Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
Novo Nordisk Investigational Site
Ottawa, Ontario, Canada, K1K 4L2
Novo Nordisk Investigational Site
Smiths Falls, Ontario, Canada, K7A 4W8
Novo Nordisk Investigational Site
Thunder Bay, Ontario, Canada, P7A 4V7
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Canada, Quebec
Novo Nordisk Investigational Site
Westmount, Quebec, Canada, H3Z 1E5
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, FI-00100
Novo Nordisk Investigational Site
Kerava, Finland, FI-04200
Novo Nordisk Investigational Site
Tampere, Finland, 33520
Novo Nordisk Investigational Site
Turku, Finland, FI-20520
Novo Nordisk Investigational Site
Ylitornio, Finland, FI-95600
Germany
Novo Nordisk Investigational Site
Aschaffenburg, Germany, 63739
Novo Nordisk Investigational Site
Bad Lauterberg, Germany, 37431
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Novo Nordisk Investigational Site
Berlin, Germany, 13055
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Gelnhausen, Germany, 63571
Novo Nordisk Investigational Site
Gifhorn, Germany, 38518
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Mannheim, Germany, 68163
Novo Nordisk Investigational Site
Mayen, Germany, 56727
Novo Nordisk Investigational Site
Oldenburg, Germany, 23758
India
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530002
Novo Nordisk Investigational Site
Rohtak, Haryana, India, 124001
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560034
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302006
Novo Nordisk Investigational Site
Kolkatta, West Bengal, India, 700031
Novo Nordisk Investigational Site
Hyderabad, India, 600034
Novo Nordisk Investigational Site
Kolkata, India, 700017
Novo Nordisk Investigational Site
Thriruvananthapuram, India, 695 032
Mexico
Novo Nordisk Investigational Site
Pachuca, Hidalgo, Mexico, 42084
Novo Nordisk Investigational Site
Mexico, D.F., México, D.F., Mexico, 03800
Netherlands
Novo Nordisk Investigational Site
Almere, Netherlands, 1315 RA
Novo Nordisk Investigational Site
Breda, Netherlands, 4811 SW
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5616 GB
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NT
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Leiden, Netherlands, 2333 ZA
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3021 HC
Novo Nordisk Investigational Site
Velp, Netherlands, 6883 ES
Novo Nordisk Investigational Site
Venlo, Netherlands, 5912 BL
Novo Nordisk Investigational Site
Zoetermeer, Netherlands, 2724 EK
Novo Nordisk Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
Serbia
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01617434     History of Changes
Other Study ID Numbers: NN2211-3917
2011-002696-41 ( EudraCT Number )
U1111-1121-9874 ( Other Identifier: WHO )
Study First Received: June 8, 2012
Results First Received: October 22, 2014
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 16, 2017