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Completed

NCT Number: NCT00825643

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Mississauga, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

insulin detemir

Drug

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

Other names: NN304, Levemir®

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia

    Time frame: during 24 weeks of treatment

Secondary outcomes

  1. Incidence of all adverse drug reactions (ADRs)

    Time frame: during 24 weeks of treatment

  2. Incidence of major and minor hypoglycaemic events

    Time frame: in the 4 weeks preceding trial start, and at the 12 and 24 week visits

  3. HbA1c and its change from trial start

    Time frame: at the 12 and 24 week visits

  4. 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

  5. FBG variability (measured as standard deviation of FBG) and its change from trial start

    Time frame: at the 12 and 24 weeks visits

  6. Body weight and its change from trial start

    Time frame: at the 12 and 24 week visits

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: SOLVE™

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2009
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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