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Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard® (EVIDENCE)

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: NCT00658099
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date April 8, 2008
First Posted Date April 14, 2008
Last Update Posted Date January 31, 2017
Study Start Date November 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2009)
Change in weight [ Time Frame: after 6 months of treatment ]
Original Primary Outcome Measures
 (submitted: April 11, 2008)
Change in weight [ Time Frame: The study duration is 6 months ]
Change History
Current Secondary Outcome Measures
 (submitted: May 12, 2009)
  • The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values [ Time Frame: after 6 months of treatment ]
  • The incidence of hypoglycaemic events [ Time Frame: after 6 months of treatment ]
  • Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints. [ Time Frame: after 6 months of treatment ]
  • The general well-being by using the WHO-5 well-being questionnaire. [ Time Frame: after 6 months of treatment ]
  • The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire [ Time Frame: after 6 months of treatment ]
  • The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit. [ Time Frame: after 6 months of treatment ]
Original Secondary Outcome Measures
 (submitted: April 11, 2008)
  • The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values [ Time Frame: The study duration is 6 months ]
  • The incidence of hypoglycaemic events [ Time Frame: The study duration is 6 months ]
  • Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints. [ Time Frame: The study duration is 6 months ]
  • The general well-being by using the WHO-5 well-being questionnaire. [ Time Frame: The study duration is 6 months ]
  • The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire [ Time Frame: The study duration is 6 months ]
  • The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit. [ Time Frame: The study duration is 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®
Official Title Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus
Brief Summary This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Type 2 diabetes patiens failing on oral anti-diabetic agents
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention
  • Drug: insulin detemir
    Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
  • Drug: insulin NPH
    Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
Study Groups/Cohorts
  • A
    Intervention: Drug: insulin detemir
  • B
    Intervention: Drug: insulin NPH
Publications * Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

*   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: March 2, 2009)
699
Original Estimated Enrollment
 (submitted: April 11, 2008)
700
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c greater than 7.0% and/or hypoglycaemia
  • variable FBG and/or weight increase
  • the selection of the subjects will be at the discretion of the participating physician

Exclusion Criteria:

  • non-type 2 diabetes
  • current treatment with Levemir® or Insulatard®
  • hypersensitivity to Levemir® or Insulatard® 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 Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT00658099
Other Study ID Numbers NN304-1976
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Public Access to Clinical Trials, Novo Nordisk A/S
Current Study Sponsor Novo Nordisk A/S
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017