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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: May 27, 2008
Last updated: August 13, 2014
Last verified: November 2012
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 Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: after 26 weeks ]
  • Number of all adverse events [ Time Frame: after 26 weeks ]
  • Number of all hypoglycemic episodes (24 hr, daytime and nocturnal) [ Time Frame: after 26 weeks ]
  • HbA1c change from baseline [ Time Frame: after 26 weeks ]
  • FBG (Fasting Blood Glucose) change from baseline [ Time Frame: after 26 weeks ]
  • Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 % [ Time Frame: after 26 weeks ]
  • Insulin dose and frequency at the end of the study [ Time Frame: after 26 weeks ]

Enrollment: 10008
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00687063

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00687063     History of Changes
Other Study ID Numbers: NN304-3530
Study First Received: May 27, 2008
Last Updated: August 13, 2014

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 processed this record on August 18, 2017