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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: insulin detemir (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Waleed AbdelFattah, MD, Study Director, Affiliation: Novo Nordisk Gulf
Hani Bakry, MSc Pharm, Study Director, Affiliation: Novo Nordisk Gulf

Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

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

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

Study design: Cohort, Prospective

Primary outcome: Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events

Secondary outcome:

Number of serious adverse events

Number of all adverse events

Number of all - daytime and nocturnal - hypoglycaemic events

Weight changes compared to baseline

HbA1c compared to baseline

Fasting glucose level control compared to baseline as measured by FBG

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

Riyadh 3542, Saudi Arabia; Recruiting

Clinical Trials at Novo Nordisk

Starting date: May 2008
Ending date: October 2009
Last updated: July 31, 2008