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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698269
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date June 13, 2008
First Posted Date June 17, 2008
Last Update Posted Date October 28, 2016
Study Start Date February 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2008)
  • Incidence of major hypoglycaemic events reported [ Time Frame: during 24 weeks of treatment ]
  • Change in HbA1c [ Time Frame: during 24 weeks of treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2008)
  • Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: at 12 & 24 weeks ]
  • Change in FPG [ Time Frame: at 12 & 24 weeks ]
  • Change in PPG [ Time Frame: at 12 & 24 weeks ]
  • Body weight [ Time Frame: at 12 & 24 weeks ]
  • Change in number of hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ]
  • Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits [ Time Frame: at 12 & 24 weeks ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 & 24 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
Official Title 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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population A non-randomized sample of Type 1 or Type 2 diabetics
Condition
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Intervention
  • 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
Study Groups/Cohorts
  • A
    Intervention: Drug: insulin detemir
  • B
    Intervention: Drug: biphasic insulin aspart 30
  • C
    Intervention: Drug: insulin aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2009)
5926
Original Estimated Enrollment
 (submitted: June 16, 2008)
5000
Actual Study Completion Date August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00698269
Other Study ID Numbers INS-3532
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2016