A Trial in Type 2 Diabetes Comparing NN9535 to Placebo and Liraglutide - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00696657

Purpose

This trial is conducted in Africa, Asia and Europe. Subjects participating in this trial will be randomised to treatment with NN9535, placebo or liraglutide. Key efficacy parameter is HbA1c and the treatment duration is 12 weeks.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: NN9535 Drug: placebo Drug: liraglutide	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Liraglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Dose Finding Trial Establishing Efficacy and Safety of NN9535 in Comparison With Placebo and Liraglutide in Type 2 Diabetes

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:

Safety [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
Antibodies [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	362
Study Start Date:	June 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: NN9535 0.1 mg, once weekly, s.c. injection
B: Experimental	Drug: NN9535 0.2 mg, once weekly, s.c. injection
C: Experimental	Drug: NN9535 0.4 mg, once weekly, s.c. injection
D: Experimental	Drug: NN9535 0.8 mg, once weekly, s.c. injection
E: Experimental	Drug: NN9535 0.8 mg with titration, once weekly, s.c. injection
F: Experimental	Drug: NN9535 1.6 mg with titration, once weekly, s.c. injection
G1: Placebo Comparator	Drug: placebo 0.1 mg, once weekly, s.c. injection
G2: Placebo Comparator	Drug: placebo 0.2 mg, once weekly, s.c. injection
G3: Placebo Comparator	Drug: placebo 0.4 mg, once weekly, s.c. injection
G4: Placebo Comparator	Drug: placebo 0.8 mg with titration, once weekly, s.c. injection
G5: Placebo Comparator	Drug: placebo 0.8 mg with titration, once weekly, s.c. injection
G6: Placebo Comparator	Drug: placebo 1.6 mg, once weekly, s.c. injection
H: Experimental	Drug: liraglutide 1.2 mg with titration, once daily, s.c. injection
I: Experimental	Drug: liraglutide 1.8 mg with titration, once daily, s.c. injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
HbA1c: 7.0-10.0 % (both inclusive)
Body weight between 60 kg and 110 kg

Exclusion Criteria:

Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
Impaired liver or kidney function
Proliferative retinopathy or maculopathy requiring acute treatment
Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
Recurrent major hypoglycaemia or hypoglycaemic unawareness
Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696657

Locations

Austria

Wien, Austria, 1010
Bulgaria

Russe, Bulgaria, 7000
Finland

Oulu, Finland, 90029
France

MONTPELLIER cedex 5, France, 34295
Germany, LÄK Hessen

Pohlheim, LÄK Hessen, Germany, 35415
Hungary

Budapest, Hungary, H-1045
India, Tamil Nadu (INDIA)

Chennai, Tamil Nadu (INDIA), India, 600020
Italy, CH

Chieti Scalo, CH, Italy, 66013
Serbia

Belgrade, Serbia, 11000
South Africa, Cape Town

Observatory, Cape Town, South Africa, 7925
Spain

Almería, Spain, 04001
Switzerland

Küsnacht, Switzerland, 8700
Turkey

Istanbul, Turkey, 34390
United Kingdom, East Sussex

Bexhill-on-Sea, East Sussex, United Kingdom, TN39 4SP

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Christine B. Jensen, MD, PhD

Novo Nordisk

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN9535-1821, EudraCT No: 2007-003956-12
Study First Received:	June 11, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00696657
Health Authority:	Austria: Federal Ministry for Health and Women; Bulgaria: Bulgarian Drug Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; India: Ministry of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Serbia: Medicines and Medical Devices Agency of Serbia; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Switzerland: Laws and standards; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Signs and Symptoms
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009