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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00709475 |
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Date of registration:
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30/06/2008 |
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Primary sponsor: |
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Public title:
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Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
LevSafeQD |
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Scientific title:
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Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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747 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00709475 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Hani Bakry, MSc Pharm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk Gulf |
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Name:
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Waleed AbdelFattah, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk Gulf |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- After the physician decision has been made to use insulin detemir therapy, any
subject with Type 2 diabetes is eligible for the study, including newly-diagnosed
subjects who have never received insulin or an insulin analogue before. The selection
of the subjects will be at the discretion of the individual physician
Exclusion Criteria:
- Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude,
inability to return for the final visit;
- Subjects currently being treated with insulin detemir;
- Subjects who previously enrolled in this study or studies related to NovoMix 30;
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
- Women who are pregnant, breast feeding or have the intention of becoming pregnant
within next 8 months.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: insulin detemir
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Primary Outcome(s)
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Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events
[Time Frame: For the duration of the study (32 weeks)]
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Secondary Outcome(s)
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Fasting glucose level control compared to baseline as measured by FBG
[Time Frame: After 16 and 32 weeks of treatment]
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HbA1c compared to baseline
[Time Frame: At the end of the study]
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Number of all - daytime and nocturnal - hypoglycaemic events
[Time Frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits]
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Number of all adverse events
[Time Frame: For the duration of the study]
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Number of serious adverse events
[Time Frame: For the duration of the study]
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Weight changes compared to baseline
[Time Frame: At the end of the study]
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Secondary ID(s)
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NN304-3551
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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