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
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 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014