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Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment (HA-BOT)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00865397
First received: March 18, 2009
Last updated: June 28, 2012
Last verified: March 2012
History of Changes
  Purpose

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5% [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist and hip circumference [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1032
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Other Names:
  • Levemir®
  • NN304

  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

A non-randomised sample of approximately 1000 subjects with OAD failure from specialists - diabetologists practice who have been deemed appropriate to receive insulin detemir as add-on to OAD therapy as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

  • Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
  • Patient willing to sign informed consent
  • Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
  • Subjects with hypersensitivity to Levemir® or to any of the ingredients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865397

Locations
Hungary
Budapest, Hungary, H-1025
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Peter Varnai, MD Novo Nordisk Hungary Ltd.
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00865397     History of Changes
Other Study ID Numbers: NN304-3699
Study First Received: March 18, 2009
Last Updated: June 28, 2012
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on May 16, 2013