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

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: NCT00687063
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

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

Study Type : Observational
Actual Enrollment : 10008 participants
Time Perspective: Prospective
Official Title: An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.
Study Start Date : April 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort Intervention/treatment
A Drug: insulin detemir
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 Name: Levemir®

Primary Outcome Measures :
  1. Weight change from baseline [ Time Frame: after 26 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetics

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

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): NCT00687063

Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00687063     History of Changes
Other Study ID Numbers: NN304-3530
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: November 2012

Additional relevant MeSH terms:
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