Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00604396

Purpose

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: insulin NPH	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir Insulin, isophane

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 of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting plasma glucose [ Designated as safety issue: No ]
Within-subject variation [ Designated as safety issue: No ]
Incidence of total hypoglycaemic episodes [ Designated as safety issue: No ]
Body weight [ Designated as safety issue: No ]
Incidence of adverse events [ Designated as safety issue: No ]
Insulin antibodies [ Designated as safety issue: No ]

Estimated Enrollment:	466
Study Start Date:	March 2003

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 months since diagnosis
Insulin naive subjects
OAD treatment for at least 4 months alone or combined with no more than two OADs
Body mass index (BMI) below 35.0 kg/m2
HbA1c between 7.5-10.0%
Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

Current or previous treatment with thiazolidiones within the last 6 months
OAD treatment with three or more OADs within the last 6 months
Acute insulin treatment for longer than 7 days in a row within the last 6 months
Secondary diabetes
Known maturity onset of diabetes of young (MODY)
Known or suspected allergy to trial product or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604396

Locations

Belgium

Arlon, Belgium, 6700
Croatia

Rijeka, Croatia, 51 000
Denmark

Hvidovre, Denmark, 2650
France

Nanterre, France, 92014
Macedonia, The Former Yugoslav Republic of

Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Norway

Elverum, Norway, 2408
Poland

Bydgoszcz, Poland, 85-094
Russian Federation

Moscow, Russian Federation, 117036
Slovakia

Trencin, Slovakia, 91171
Sweden

TRELLEBORG, Sweden, 231 85

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jens Larsen

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:	NN304-1530
Study First Received:	January 17, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00604396
Health Authority:	Belgium: Directorate General for the Protection of Public Health: Medici; Croatia: Ministry of Health and Social Care; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health; Norway: Norwegian Medicines Agency; Poland: The Office for Reg. of Medicinal Products, Medical Devices; Russia: Federal Service for Control of Health Care and Social Developme; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009