Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes (SOLVE™)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00825643

First received: January 20, 2009

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2009

Last Updated Date

June 28, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00825643 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of all adverse drug reactions (ADRs) [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Incidence of major and minor hypoglycaemic events [ Time Frame: in the 4 weeks preceding trial start, and at the 12 and 24 week visits ] [ Designated as safety issue: Yes ]
HbA1c and its change from trial start [ Time Frame: at the 12 and 24 week visits ] [ Designated as safety issue: No ]
Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start [ Time Frame: at the 12 and 24 week visits ] [ Designated as safety issue: No ]
FBG variability (measured as standard deviation of FBG) and its change from trial start [ Time Frame: at the 12 and 24 weeks visits ] [ Designated as safety issue: No ]
Body weight and its change from trial start [ Time Frame: at the 12 and 24 week visits ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

Brief Summary

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.

Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir

Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation

Other Name: NN304, Levemir®

Study Group/Cohort (s)

Insulin detemir

Intervention: Drug: insulin detemir

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

16454

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

Current treatment with insulin
Known or suspected allergy to Levemir® or excipients
Children below the age of 6 years
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, China, Germany, Israel, Italy, Poland, Portugal, Spain, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00825643

Other Study ID Numbers ^ICMJE

NN304-3714

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christoph Koenen, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top