Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700765
• Other study ID #: NN304-3528
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: October 27, 2016
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1531
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

• Subjects who are unlikely to comply with the protocol

• Subjects who are currently being treated with Levemir®

• Subjects who previously were enrolled into the study

• Subjects with hypersensitivity to Levemir® or any of its excipients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation

Locations

Country	Name	City	State
Indonesia	Novo Nordisk Investigational Site	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions (SADRs)		during treatment	Yes
Primary	Major hypoglycaemic events		during treatment	Yes
Secondary	Number of serious adverse events		during treatment	Yes
Secondary	Number of all adverse events		during treatment	Yes
Secondary	Number of all hypoglycaemic events		the last 4 weeks of treatment	Yes
Secondary	Weight changes		after 12 weeks	No
Secondary	HbA1c		after 12 weeks and 26 weeks of treatment	No
Secondary	Variability in fasting blood glucose (FBG) and average plasma glucose level		after 12 weeks	No

External Links

•   Clinical Trials at Novo Nordisk