Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00604253
First received: January 17, 2008
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 36 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Insulin antibodies [ Designated as safety issue: No ]

Enrollment: 362
Study Start Date: December 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Duration of type 2 diabetes mellitus for at least one year
  • Insulin naive patients
  • OHA treatment for at least 12 weeks
  • HbA1C between 7.5-10.0%
  • Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

  • Impaired renal function
  • Impaired hepatic function
  • Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604253

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tatsuya Sasako Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00604253     History of Changes
Other Study ID Numbers: NN304-1477, JapicCTI-R070009
Study First Received: January 17, 2008
Last Updated: June 19, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on April 16, 2014