NCT00825643|Completed

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

SOLVE™

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN304-3714

Study Type

observational

Target

18,481

Locations

9 countries

Sites

Timeline

RegisteredJan 2009

StartedApr 2008

CompletionMar 2011

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

18,481

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach

9 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

April 1, 2008

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

January 20, 2009

Last Update Submit

February 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
during 24 weeks of treatment

Secondary Outcomes (6)

Incidence of all adverse drug reactions (ADRs)
during 24 weeks of treatment
Incidence of major and minor hypoglycaemic events
in the 4 weeks preceding trial start, and at the 12 and 24 week visits
HbA1c and its change from trial start
at the 12 and 24 week visits
Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start
at the 12 and 24 week visits
FBG variability (measured as standard deviation of FBG) and its change from trial start
at the 12 and 24 weeks visits
+1 more secondary outcomes

Study Arms (1)

Insulin detemir

Drug: insulin detemir

Interventions

insulin detemirDRUG

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

Also known as: NN304, Levemir®

Insulin detemir

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.