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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00687063
First received: May 27, 2008
Last updated: June 28, 2012
Last verified: September 2009
History of Changes
  Purpose

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 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Weight change from baseline [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all adverse events [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all hypoglycemic episodes (24 hr, daytime and nocturnal) [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c change from baseline [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • FBG (Fasting Blood Glucose) change from baseline [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 % [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and frequency at the end of the study [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 9868
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®

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetics

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687063

Locations
India
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anil Shinde Shinde, MD Novo Nordisk India Private Limited.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00687063     History of Changes
Other Study ID Numbers: NN304-3530
Study First Received: May 27, 2008
Last Updated: June 28, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013