Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes. - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00469092

Purpose

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: glimepiride	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Glimepiride Insulin aspart 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:	Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin Naive Subjects With Type 2 Diabetes.

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:

9-point plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Percentage of subjects reaching certain levels of HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Number of hypoglycaemic episodes [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
Treatment Satisfaction [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Adverse events (AEs) [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	480
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: biphasic insulin aspart Treat-to-target dose titration scheme Drug: metformin Tablets, 2550 mcg. Administered once daily Drug: glimepiride tablets 2 mg. 4, 6 or 8 mg administered once daily
B: Active Comparator	Drug: insulin glargine Treat-to-target dose titration scheme Drug: metformin Tablets, 2550 mcg. Administered once daily Drug: glimepiride tablets 2 mg. 4, 6 or 8 mg administered once daily

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes
Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
Ongoing stable treatment with metformin for at least 2 months
Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
Insulin naive
HbA1c between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

Metformin contraindication according to local practice
TZD treatment for the last 5 months before trial start
Systemic treatment with any corticosteroid 3 months before trial start
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: NCT00469092

Locations

Argentina

Buenos Aires, Argentina, C1405CWB
Austria

Traisen, Austria, 3160
Czech Republic

Prague, Czech Republic
France

Paris, France
India

Karnal, India, 132001
Malaysia

Kuala Lumpur, Malaysia
Mexico

Mexico City, Mexico, 44340
Netherlands

Rotterdam, Netherlands, 3021 HC
Philippines

Manila, Philippines
Poland

Zabrze, Poland
Romania

Bucharest, Romania
South Africa

Brits, South Africa, 0205
Spain

Madrid, Spain, 28040
Sweden

Stockholm, Sweden

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Pernille Gad, MSc

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 A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1731, EudraCT No: 2006-003288-29
Study First Received:	May 3, 2007
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00469092 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Poland: Ministry of Health; Serbia: Medicines and Medical Devices Agency of Serbia; South Africa: Medicines Control Council; Czech Republic: State Institute for Drug Control; Austria: Federal Ministry for Health and Women; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia; Philippines: Bureau of Food and Drugs; Romania: National Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCM; Sweden: Medical Products Agency; Mexico: National Council of Science and Technology; Malaysia: Ministry of Health; India: India's Drug Controller General, a division of the Ministry of

Study placed in the following topic categories:

Metabolic Diseases
Immunologic Factors
Metformin
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Insulin
Glimepiride

Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glargine
Insulin, Asp(B28)-
Anti-Arrhythmia Agents
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Insulin

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Glargine
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009