Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00669864

Purpose

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart 30 Drug: metformin	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Metformin Metformin hydrochloride Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

8-point plasma glucose profile [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Percentage of subjects achieving HbA1c less than 7.0% [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Percentage of subjects achieving HbA1c below or equal to 6.5% [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	266
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: biphasic insulin aspart 30 S.c. injection, twice daily Drug: metformin Tablets, 1000 - 2000 mg 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
Currently treated with basal insulin once or twice daily with or without OAD(s) for at least 3 months
HbA1c within the range of 7.5% to10.0% ( both incl.)
BMI is not more than 40 kg/m2

Exclusion Criteria:

Metformin contraindications according to local practice
Systemically treated with TZDs for more than one month within 6 months prior to this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669864

Locations

China

Beijing, China, 100034

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Ruifang LIANG	Novo Nordisk
Study Director:	HONGFEI XU	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:	BIASP-1960
Study First Received:	April 29, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00669864
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
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 16, 2009