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Completed

NCT Number: NCT00687284

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Košice, 040 01, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Other names: Levemir®

Primary outcomes

  1. Change in glycaemic control as measured by HbA1c.

    Time frame: For the duration of the study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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.

Acronym: START

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 30, 2008
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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