Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

This study has been completed.

First Received: January 25, 2006 Last Updated: May 14, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00282451

Purpose

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Glycemic Control of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Metformin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: At Visit 6 (14 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles) [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	February 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetic subjects.
Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial.
HbA1c = 12%.
Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

History of drug or alcohol dependence.
Receipt of any investigational drug within the last month prior to this trial.
Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids).
Severe uncontrolled hypertension
Recurrent severe hypoglycemia as judged by investigator
Any disease or condition, which the Investigator feels, would interfere with the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282451

Locations

Egypt

Cairo, Egypt
Saudi Arabia

Riyadh, Saudi Arabia

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Rasha El Kassas

Novo Nordisk Egypt

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-3024
Study First Received:	January 25, 2006
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00282451 History of Changes
Health Authority:	Saudi Arabia: Ministry of Health; Egypt: Ministry of Health and Population

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 02, 2009