Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00627445

Purpose

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart 30 Drug: metformin Drug: biphasic insulin aspart 50	Phase III

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, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	440
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: biphasic insulin aspart 30 Treat-to-target dose titration scheme, s.c. injection before dinner Drug: metformin Tablets, 500 - 2000 mg, once, twice or three times daily Drug: biphasic insulin aspart 50 Treat-to-target dose titration scheme, s.c. injection before breakfast and lunch
B: Active Comparator	Drug: metformin Tablets, 500 - 2000 mg, once, twice or three times daily Drug: biphasic insulin aspart 30 Treat-to-target dose titration scheme, s.c. injection before breakfast and dinner

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 premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
HbA1c between 7.5% - 12.0% (both inclusive)
FPG higher than 7.0 mmol/l
BMI 23-40 kg/sq.m (both inclusive)

Exclusion Criteria:

Metformin contraindications according to local practice
Systemic use of TZDs for more than 1 month within 6 months prior to this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627445

Locations

China

Beijing, China, 100034

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Xu Hongfei, MSc

Novo Nordisk (China) Pharmaceuticals Co., Ltd.

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-1858
Study First Received:	February 22, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00627445
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