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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)
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 20, 2005
Last updated: March 3, 2016
Last verified: March 2016
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Plasma glucose levels
  • Percentage of subjects achieving the treatment target of HbA1c value < 6.5%

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)

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00267683

Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00267683     History of Changes
Other Study ID Numbers: ANA-1667
JapicCTI-060200 ( Registry Identifier: JAPIC )
Study First Received: December 20, 2005
Last Updated: March 3, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017