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Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus (START)

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. Identifier: NCT00687284
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : October 28, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.

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

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Study Type : Observational
Actual Enrollment : 2188 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.
Study Start Date : February 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change in glycaemic control as measured by HbA1c. [ Time Frame: For the duration of the study ]

Secondary Outcome Measures :
  1. Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% [ Time Frame: After 12 weeks and 24 weeks ]
  2. The effect on glycaemic control as measured by FPG [ Time Frame: After 12 weeks and 24 weeks ]
  3. Change in body weight [ Time Frame: After 12 weeks and 24 weeks ]
  4. Change in waist and hip perimeter [ Time Frame: After 12 weeks and 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Diabetes mellitus type 2

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Patients inadequately controlled by OAD
  • Patients willing to sign informed consent
  • Selection of study participants at the discretion of the physician
  • Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breastfeeding 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 identifier (NCT number): NCT00687284

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Novo Nordisk Investigational Site
Kosice, Slovakia, 040 01
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00687284    
Other Study ID Numbers: NN304-3515
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs