Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™

This study has been completed.

First Received: May 6, 2008 Last Updated: September 4, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00675220

Purpose

This study is conducted in Asia.

The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.

Condition	Intervention
Diabetes Mellitus	Drug: insulin aspart

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™ in the Treatment of Acute Hyperglycemia

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Safety profile of Insulin Aspart among Filipino patients [ Time Frame: 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	300
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	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:	Non-Probability Sample

Study Population

Patients with Diabetes

Criteria

Inclusion Criteria:

Patients with diabetes mellitus (according to product labelling)

Exclusion Criteria:

Hypoglycaemia
Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675220

Locations

Philippines

Manila, Philippines, 1605

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Dixie Pritzel C. Calpatura

Novo Nordisk

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:	ANA-1884
Study First Received:	May 6, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00675220 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
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

ClinicalTrials.gov processed this record on September 10, 2009