Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01542060
First received: February 15, 2012
Last updated: April 11, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2012 | ||||
| Last Updated Date | April 11, 2012 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01542060 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus | ||||
| Official Title ICMJE | A Clinical Experience Programme to Collect Data on the Safety and Efficacy of NovoMix® 30 in the Treatment of Patients With Type 2 Diabetes in Jordan | ||||
| Brief Summary | This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients from hospitals or clinics diagnosed with type 2 diabetes mellitus |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: biphasic insulin aspart 30
Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician |
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| Study Group/Cohort (s) | BIAsp 30 users
Intervention: Drug: biphasic insulin aspart 30 |
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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 | 298 | ||||
| Completion Date | December 2004 | ||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Jordan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01542060 | ||||
| Other Study ID Numbers ICMJE | BIASP-1892 | ||||
| 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 | April 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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