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

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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

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin NPH

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Study Type : Observational
Actual Enrollment : 699 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A Drug: insulin detemir
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

B Drug: insulin NPH
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation




Primary Outcome Measures :
  1. Change in weight [ Time Frame: after 6 months of treatment ]

Secondary Outcome Measures :
  1. The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values [ Time Frame: after 6 months of treatment ]
  2. The incidence of hypoglycaemic events [ Time Frame: after 6 months of treatment ]
  3. Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints. [ Time Frame: after 6 months of treatment ]
  4. The general well-being by using the WHO-5 well-being questionnaire. [ Time Frame: after 6 months of treatment ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes patiens failing on oral anti-diabetic agents
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658099


Locations
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Romania
Novo Nordisk Investigational Site
Bucharest, Romania, 010031
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00658099     History of Changes
Other Study ID Numbers: NN304-1976
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs