Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00592969

Purpose

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Metformin Metformin hydrochloride Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:

PPBG values
Glucose profiles
Hypoglycemia
Adverse events

Estimated Enrollment:	160
Study Start Date:	December 2003

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 insulin NPH or are insulin-naive
Body mass index (BMI) below 35.0 kg/m2
HbA1c between 7.5-11.0%

Exclusion Criteria:

Participation in any other clinical trial involving investigational products within the last 3 months
History of drug or alcohol dependence
Known impaired hepatic function
Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592969

Locations

Argentina

Mariano Acosta s/n, Argentina, 5016
Brazil, mg

Belo Horizonte, mg, Brazil, 30190-130

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Plamen Kozlovski

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-1570
Study First Received:	January 2, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00592969
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency

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, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009