An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-Diabetic Treatment - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00698269

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Condition	Intervention
Diabetes Mellitus	Drug: insulin detemir Drug: biphasic insulin aspart 30 Drug: insulin aspart

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of major hypoglycaemic events reported [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Change in HbA1c [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Change in FPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Change in PPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Change in number of hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
Number of adverse drug reactions (ADR) [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
B	Drug: biphasic insulin aspart 30 Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
C	Drug: insulin aspart Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

A non-randomized sample of Type 1 or Type 2 diabetics

Criteria

Inclusion Criteria:

Type 1 or type 2 diabetes
Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
Selection will be at the discretion of the individual physician

Exclusion Criteria:

Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
Previous enrolled in this study
Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698269

Locations

Saudi Arabia

Riyadh, Saudi Arabia, 3542

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Waleed AbdelFattah AbdelFattah, MD

Novo Nordisk Pharma Gulf

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:	INS-3532
Study First Received:	June 13, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00698269 History of Changes
Health Authority:	Saudi Arabia: Ministry of Health; United Arab Emirates: Ministry of Health; Oman: Ministry of Health; Kuwait: Ministry of Health; Bahrain: Ministry of Health; Qatar: Ministry of Health

Study placed in the following topic categories:

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

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009