Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes (PRESENT)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01536600
First received: February 16, 2012
Last updated: April 11, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2012 | ||||
| Last Updated Date | April 11, 2012 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in 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 NCT01536600 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 | Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes | ||||
| Official Title ICMJE | A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice | ||||
| Brief Summary | This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice. |
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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 with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30) |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: biphasic insulin aspart 30
The insulin dose and regimen was individualised at the physician's discretion |
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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 | 33010 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | December 2006 (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 | China, India, Iraq, Jordan, Korea, Republic of, Lebanon, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Turkey | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01536600 | ||||
| Other Study ID Numbers ICMJE | BIASP-1880 | ||||
| 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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