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

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ClinicalTrials.gov Identifier: NCT00825643
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.


Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Design
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Study Type : Observational
Actual Enrollment : 18481 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Study Start Date : April 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Insulin detemir 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®


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia [ Time Frame: during 24 weeks of treatment ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825643


Locations
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Canada
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Portugal
Novo Nordisk Investigational Site
Paco de Arcos, Portugal, 2780-730
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34335
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00825643     History of Changes
Other Study ID Numbers: NN304-3714
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs