Observational Study on Safety of Self-Titration of Once Daily Levemir® - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00740519

Purpose

This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.

The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation on Safety of Self-Titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of serious adverse drug reactions including major hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of serious adverse events and all adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Incidence of hypoglycaemic events [ Time Frame: in the 4 weeks preceding the baseline, 12 and 20 week visits ] [ Designated as safety issue: Yes ]
HbA1c [ Time Frame: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks ] [ Designated as safety issue: No ]
Variability and mean of the patient's self-monitored plasma glucose measurements [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo [ Time Frame: defined by the average of the last three FBGs ] [ Designated as safety issue: No ]
Body weight [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
Frequency of insulin adjustment [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
Total number of visits/contacts to the clinic, related to titration [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
HCP time used on titration training [ Time Frame: at baseline and approximately 12 and 20 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 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 a normal clinical evaluation.

Eligibility

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

Study Population

Patients from a primary care setting who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing health care professional.

Criteria

Inclusion Criteria:

After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

Patients unable to give written informed consent
Current treatment with insulin
Patient deemed unable or unwilling to self-titrate
Known or suspected allergy to study product or related products
Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740519

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

United Kingdom, West Sussex
	Recruiting
Crawley, West Sussex, United Kingdom, RH11 9RT

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Darren Herger	Novo Nordisk UK Ltd.
Study Director:	Hilary Twigg	Novo Nordisk UK Ltd.

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3573
Study First Received:	August 19, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00740519
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009