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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 ]

Estimated Enrollment:	446
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617434

Show 39 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Nikolaj Ture Gregersen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
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:	April 9, 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 May 16, 2013