Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication (A1chieve)
Tracking Information
Start Date ICMJE | January 2009 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: March 25, 2009) | Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00869908 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: March 25, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication |
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Official Title ICMJE | The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study |
Brief Summary | This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion |
Detailed Description | |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Cohort, Prospective |
Condition ICMJE | Diabetes Mellitus, Type 2 |
Intervention ICMJE |
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Study Arms / Comparison Groups | A Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 60000 | ||||
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Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Algeria, Argentina, Bangladesh, Brazil, China, Egypt, India, Indonesia, Iran, Islamic Republic of, Jordan, Korea, Republic of, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Pakistan, Philippines, Russian Federation, Saudi Arabia, Taiwan, Tunisia, Turkey |
Administrative Information
NCT ID ICMJE | NCT00869908 | ||||
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Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||
Study ID Numbers ICMJE | INS-3693 | ||||
Study Sponsor ICMJE | Novo Nordisk | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novo Nordisk |
Source: http://clinicaltrials.gov/