Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

This study has been completed.

First Received on September 12, 2005. Last Updated on May 13, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184626

Purpose

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Insulin aspart Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: Measured at end of treatment (26 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety variables [ Designated as safety issue: No ]
other glycemic variables [ Designated as safety issue: No ]
Fasting plasma glucose value [ Designated as safety issue: No ]

Enrollment:	97
Study Start Date:	September 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
Body mass index equal to or lesser than 35.0 kg/m2
Currently treated with oral hypoglycaemic drug

Exclusion Criteria:

Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184626

Locations

Turkey

Istanbul, Turkey

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Sebnem A. Tuna, MD

Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti.

More Information

Additional Information:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00184626 History of Changes
Other Study ID Numbers:	BIASP-1594
Study First Received:	September 12, 2005
Last Updated:	May 13, 2009
Health Authority:	Turkey: Ministry of Health Drug and Pharmaceutical Department

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Glargine

Insulin
Metformin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012