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 A/S
ClinicalTrials.gov Identifier:
NCT00865397
First received: March 18, 2009
Last updated: June 28, 2012
Last verified: March 2012
  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:


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

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
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: NCT00865397

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

Additional Information:
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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014