Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00614055

Purpose

This trial is conducted in Europe. The aim of the trial is to compare two NN5401 formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: NN5401 Drug: insulin glargine Drug: metformin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy Comparison of Two NN5401 Formulations and Insulin Glargine, All in Combination With Metformin in Insulin Naive Subjects With Type 2 Diabetes, Measured by HbA1c After 16 Weeks of Treatment

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Laboratory safety parameters [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	177
Study Start Date:	January 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: NN5401 Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily Drug: metformin Tablets, 1500-2000 mg/day
B: Experimental	Drug: NN5401 Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily Drug: metformin Tablets, 1500-2000 mg/day
C: Active Comparator	Drug: insulin glargine Treat-to-target dose titration scheme, injection s.c., once daily Drug: metformin Tablets, 1500-2000 mg/day

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Insulin naive type 2 subjects for at least 3 months
Treatment with a stable dosing of maximally tolerated dose or at least half maximally allowed dose of one or two OADs for at least 2 months
HbA1c 7-11% (both inclusive)
Body mass index (BMI) 25-37 kg/m2 (both inclusive)

Exclusion Criteria:

Metformin contraindication according to local practice
Treatment with thiazolidinedione (TZD) within 3 months prior to screening
Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) 3 months prior to randomisation
Any disease or condition which according to the investigator would interfere with the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614055

Locations

France

Mont de Marsan, France, 40024
Germany, LÄK Rheinland-Pfalz

Neuwied, LÄK Rheinland-Pfalz, Germany, 56564
Norway

Sandvika, Norway, NO-1337
Romania, 011234

Bucharest, 011234, Romania
Spain, Alicante

Baracot, Alicante, Spain, 03114

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Benedikte J. Lertoft, DVM

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:	NN5401-1791, EudraCT No: 2007-002476-33
Study First Received:	January 30, 2008
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00614055
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009