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

Diabetes Mellitus, Type 2 Clinical Trial

— LevSafeQD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709475
• Other study ID #: NN304-3551
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: October 27, 2016
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of HealthUnited Arab Emirates: Ministry of HealthKuwait: Ministry of HealthOman: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events		For the duration of the study (32 weeks)	Yes
Secondary	Number of serious adverse events		For the duration of the study	Yes
Secondary	Number of all adverse events		For the duration of the study	Yes
Secondary	Number of all - daytime and nocturnal - hypoglycaemic events		In the 4 weeks before baseline compared to 4 weeks before interim and final visits	Yes
Secondary	Weight changes compared to baseline		At the end of the study	No
Secondary	HbA1c compared to baseline		At the end of the study	No
Secondary	Fasting glucose level control compared to baseline as measured by FBG		After 16 and 32 weeks of treatment	No

External Links

•   Clinical Trials at Novo Nordisk