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An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00698269
First received: June 13, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes

June 13, 2008
July 12, 2012
February 2008
August 2009   (final data collection date for primary outcome measure)
  • Incidence of major hypoglycaemic events reported [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: during 24 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00698269 on ClinicalTrials.gov Archive Site
  • Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in PPG [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: No ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 & 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

A non-randomized sample of Type 1 or Type 2 diabetics
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
    Other Name: Levemir®
  • Drug: biphasic insulin aspart 30
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
  • Drug: insulin aspart
    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
  • A
    Intervention: Drug: insulin detemir
  • B
    Intervention: Drug: biphasic insulin aspart 30
  • C
    Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5926
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
  • Selection will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
  • Previous enrolled in this study
  • Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT00698269
INS-3532
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Waleed AbdelFattah AbdelFattah, MD Novo Nordisk Pharma Gulf
Novo Nordisk
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP