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 A/S
ClinicalTrials.gov Identifier:
NCT00687063
First received: May 27, 2008
Last updated: June 28, 2012
Last verified: September 2009
  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:


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

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
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 ClinicalTrials.gov identifier: NCT00687063

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
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 July 24, 2014