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  ICMJEJanuary 2009
Estimated Primary Completion DateDecember 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  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00869908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: March 25, 2009)
  • Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial glucose) [ Time Frame: at baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEObservational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication
Official Title  ICMJEThe 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  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: insulin aspart
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
    Other Names:
    • NovoRapid®
    • ANA
  • Drug: insulin detemir
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
    Other Names:
    • Levemir®
    • NN304
  • Drug: biphasic insulin aspart
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
    Other Names:
    • NovoMix® 30
    • NovoMix®
    • BIASP
Study Arms / Comparison GroupsA
Interventions:
  • Drug: insulin aspart
  • Drug: insulin detemir
  • Drug: biphasic insulin aspart

Recruitment Information

Estimated Enrollment  ICMJE60000
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
  • The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

  • Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
  • Subjects who were previously enrolled in this study.
  • Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.
GenderBoth
Ages 
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Access to Clinical Trials - Novo NordiskPlease Contact NN via emailclinicaltrials@novonordisk.com
Location Countries  ICMJEAlgeria,   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  ICMJENCT00869908
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJEINS-3693
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Praful Chakkarwar, MBBS, MDNovo Nordisk International Operations
Information Provided ByNovo Nordisk