Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes (PREDICTIVE™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00655044
First received: April 4, 2008
Last updated: July 24, 2012
Last verified: July 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2008 | ||||
| Last Updated Date | July 24, 2012 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HbA1C [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00655044 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: during treatment ] [ Designated as safety issue: Yes ] | ||||
| 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 | Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes | ||||
| Official Title ICMJE | Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus | ||||
| Brief Summary | This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Type 1 and type 2 diabetes patients |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
Other Names:
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| Study Group/Cohort (s) | Type 1 and type 2 diabetes patients
Intervention: Drug: insulin detemir |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 3753 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Russian Federation | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00655044 | ||||
| Other Study ID Numbers ICMJE | NN304-3514 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||
| Study Sponsor ICMJE | Novo Nordisk | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novo Nordisk | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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