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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00604253
First received: January 17, 2008
Last updated: January 26, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Plasma glucose profiles
  • Incidence of hypoglycaemic episodes
  • Adverse events
  • Insulin antibodies

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00604253

Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00604253     History of Changes
Other Study ID Numbers: NN304-1477
JapicCTI-R070009 ( Registry Identifier: japic )
Study First Received: January 17, 2008
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Isophane Insulin, Human
Insulin, Isophane
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017