Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes - Full Text View

Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00318786

Purpose

This trial is conducted in Japan.

This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart	Phase III

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Hemoglobin A1C (HbA1C) [ Time Frame: After 16 weeks of treatment ]

Secondary Outcome Measures:

HbA1C, after 28 weeks of treatment; Plasma glucose levels

Estimated Enrollment:	284
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with type 2 diabetes
Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin = 24 weeks
HbA1C = 7.5% and < 10.0%

Exclusion Criteria:

Proliferative retinopathy or maculopathy requiring acute treatment
Impaired hepatic and/or renal function
Cardiac diseases
Uncontrolled hypertension
Known hypoglycemia unawareness or recurrent major hypoglycemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318786

Locations


Japan

	Sendai, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Michiaki Kanai, DVM, MSc.	Novo Nordisk Pharma Limited Japan

More Information

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

Study ID Numbers:	BIASP-1598, JapicCTI-060241
First Received:	April 26, 2006
Last Updated:	September 5, 2007
ClinicalTrials.gov Identifier:	NCT00318786
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Metabolic Diseases

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 October 06, 2008