Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00698126

Purpose

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: soluble human insulin Drug: biphasic insulin aspart

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Multicentre, Open Label, Nonrandomised, Non-Interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Number of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious and non serious drug reactions [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
Number of serious adverse event [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
Number of major hypoglycaemic events related to omission of a meal after injection [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
Number of major hypoglycaemic events related to physical exercise of at least 30 min duration [ Time Frame: during 26 weeks ] [ Designated as safety issue: Yes ]
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
Weight and waist circumference change [ Time Frame: during 26 weeks ] [ Designated as safety issue: No ]
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
Quality of Life (QoL) [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: soluble human insulin Observational study; use of the products as in the normal clinical practice conditions
B	Drug: biphasic insulin aspart Observational study; use of the products as in the normal clinical practice conditions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study

Criteria

Inclusion Criteria:

Patients with type 2 diabetes
Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria:

Patients with an end-stage renal failure
Patients with a serious liver disease
Patients with concomitant malignant disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698126

Locations

Italy

Rome, Italy, 00144

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Annamaria Matera

Novo Nordisk Farmaceutici SpA

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-1897
Study First Received:	June 13, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00698126 History of Changes
Health Authority:	Italy: Ethics Committee

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
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009