Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00619697

Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Glimepiride Insulin aspart Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

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:

HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Plasma glucose profiles [ Designated as safety issue: No ]
Change in body mass index [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
Safety profile [ Designated as safety issue: No ]

Enrollment:	260
Study Start Date:	December 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Other Names:

BIASP
NovoMix 30
NovoLog 70/30 Mix

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 6 months
Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
Previous treatment with oral antidiabetic drugs for at least 4 months
Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
BMI below 40 kg/m2
HbA1c between 7-12%
Able and willing to perform self-plasma glucose monitoring

Exclusion Criteria:

The receipt of any other investigational drug within 4 weeks before screening
A history of drug or alcohol abuse within the last 12 months
Severe, uncontrolled hypertension
Known or suspected allergy to trial products or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619697

Locations

Austria

Graz, Uni Graz, Austria, 8036
Czech Republic

Brno, Czech Republic, 65691
Germany

Marburg, EK Uni Marburg, Germany, 35043
Hungary

Budapest, Hungary, 1041
Poland

Otwock, Poland, 05-400
Slovakia

Martin, Slovakia, 036 59
Slovenia

Ljubljana, Slovenia, 1000

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Plamen Kozlovski

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00619697 History of Changes
Other Study ID Numbers:	BIASP-1564
Study First Received:	February 11, 2008
Last Updated:	May 13, 2009
Health Authority:	Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials; Slovakia: State Institute for Drug Control; Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials; Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin aspart
Glargine
Insulin
Metformin

Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012