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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00624364

Purpose

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart 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:	Comparion of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 24 weeks of treatment ]

Secondary Outcome Measures:

Plasma glucose profiles
Cardiovascular risk factors
Incidence of hypoglycaemic episodes
Adverse events

Estimated Enrollment:	160
Study Start Date:	May 2004

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 maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
Body mass index (BMI) below 40.0 kg/m2
HbA1c between 7.5-13.0%

Exclusion Criteria:

History of drug or alcohol dependence
Mental incapacity, unwillingness or language barriers precluding adequate
Subjects previously screened to participation or having already participated in this trial
Receipt of any investigational drug within the last month prior to this trial
Known or suspected allergy to trial products or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624364

Locations

South Africa

Brits, South Africa, 0205

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Timothy Kedijang, MBChB, MSc

Novo Nordisk Pty. 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-1579
Study First Received:	February 15, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00624364
Health Authority:	South Africa: Medicines Control Council

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