Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700765
First received: June 18, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions (SADRs) [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Major hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Number of all adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Number of all hypoglycaemic events [ Time Frame: the last 4 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Weight changes [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: after 12 weeks and 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Variability in fasting blood glucose (FBG) and average plasma glucose level [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 1531
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion

Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

  • Subjects who are unlikely to comply with the protocol
  • Subjects who are currently being treated with Levemir®
  • Subjects who previously were enrolled into the study
  • Subjects with hypersensitivity to Levemir® or any of its excipients
  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: NCT00700765

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sri I Soetomo, MD Novo Nordisk Indonesia
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700765     History of Changes
Other Study ID Numbers: NN304-3528
Study First Received: June 18, 2008
Last Updated: July 24, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014