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Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

This study has been terminated.
(This trial was terminated due to low recruitment)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00267683
First received: December 20, 2005
Last updated: April 12, 2013
Last verified: November 2012
  Purpose

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin aspart
Drug: glibenclamide
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: A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Plasma glucose levels [ Designated as safety issue: No ]
  • Percentage of subjects achieving the treatment target of HbA1c value < 6.5% [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: December 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (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:

  • Type 2 diabetes
  • Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
  • No previous treatment with insulin and/or SU agents
  • HbA1c between 7.5% and 10.0%
  • Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with systemic corticosteroids
  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: NCT00267683

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michiaki Kanai, DVM, MSc. Novo Nordisk Pharma Limited Japan
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00267683     History of Changes
Other Study ID Numbers: ANA-1667, JapicCTI-060200
Study First Received: December 20, 2005
Last Updated: April 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glyburide
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014