Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00518882

Purpose

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: exenatide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
7-point plasma glucose profiles (self-measured) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Fraction of subjects reaching target HbA1c of less than 7.0% or less than or equal to 6.5% [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Beta-cell function and lipid profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Hypoglycaemic episodes and adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]

Enrollment:	467
Study Start Date:	August 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 1.8 mg once daily for s.c. injection.
B: Active Comparator	Drug: exenatide 10 mcg twice daily for s.c. injection.

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes
Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
BMI equal to or lower than 45.0 kg/m2

Exclusion Criteria:

Previous treatment with insulin
Treatment with any anti-diabetic drug other than metformin and sulphonylurea
Any previous exposure to exenatide or liraglutide
Impaired liver or/and renal function
History of any significant cardiac events
Known retinopathy or maculopathy requiring acute treatment
Recurrent major hypoglycaemia or hypoglycaemic unawareness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518882

Show 72 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Marcin Zychma, MD, PhD

Novo Nordisk

More Information

Additional Information:

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1797, EudraCT No: 2006-006092-21
Study First Received:	August 20, 2007
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00518882 History of Changes
Health Authority:	United States: Food and Drug Administration; Finland: Finnish Medicines Agency; Switzerland: Swissmedic; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Austria: Federal Ministry for Health and Women; Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials; Denmark: Danish Medicines Agency; Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health; Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic; Romania: National Medicines Agency; Sweden: Medical Products Agency

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010