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Completed

NCT Number: NCT00687063

Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

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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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bangalore, 560001, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any subject with type 2 diabetes

Exclusion criteria

  • Subjects with a hypersensitivity to insulin detemir or any of its excipient
  • Children below 6 years
  • Subjects who are pregnant, lactating or planning to become pregnant

Treatment and study plan

insulin detemir

Drug

Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician

Other names: Levemir®

Primary outcomes

  1. Weight change from baseline

    Time frame: after 26 weeks

Secondary outcomes

  1. Number of serious adverse events

    Time frame: after 26 weeks

  2. Number of all adverse events

    Time frame: after 26 weeks

  3. Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)

    Time frame: after 26 weeks

  4. HbA1c change from baseline

    Time frame: after 26 weeks

  5. FBG (Fasting Blood Glucose) change from baseline

    Time frame: after 26 weeks

  6. Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %

    Time frame: after 26 weeks

  7. Insulin dose and frequency at the end of the study

    Time frame: after 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.

Acronym: DIABESITY

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Nov 2, 2023

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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