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: August 7, 2014
Last verified: August 2014
  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 Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] target) [ Time Frame: Week 0 to Week 26 ] [ 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: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Number of Adverse Events (AEs) During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Number of subjects with severe hypoglycaemic episodes During The Randomised Treatment Period [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]

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
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

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: August 7, 2014
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
Liraglutide
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 August 20, 2014