Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00709475

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events [ Time Frame: For the duration of the study (32 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious adverse events [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
Number of all adverse events [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
Number of all - daytime and nocturnal - hypoglycaemic events [ Time Frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits ] [ Designated as safety issue: Yes ]
Weight changes compared to baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
HbA1c compared to baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Fasting glucose level control compared to baseline as measured by FBG [ Time Frame: After 16 and 32 weeks of treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	May 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 the normal clinical evaluation

Eligibility

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

Study Population

Type 2 diabetic patients

Criteria

Inclusion Criteria:

After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit;
Subjects currently being treated with insulin detemir;
Subjects who previously enrolled in this study or studies related to NovoMix 30;
Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709475

Locations

Saudi Arabia

Riyadh, Saudi Arabia, 3542

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Waleed AbdelFattah, MD	Novo Nordisk Gulf
Study Director:	Hani Bakry, MSc Pharm	Novo Nordisk 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:	NN304-3551
Study First Received:	June 30, 2008
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00709475 History of Changes
Health Authority:	Saudi Arabia: Ministry of Health; United Arab Emirates: Ministry of Health; Kuwait: Ministry of Health; Oman: Ministry of Health

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 27, 2009