Efficacy and Safety of Insulin Aspart Versus Glibenclamide Thrice Daily in Type 2 Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: insulin aspart (Drug); glibenclamide (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Michiaki Kanai, DVM, MSc., Study Director, Affiliation: Novo Nordisk Pharma Limited Japan
Summary
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.
Clinical Details
Official title: A Clinical Trial to Study the Efficacy and Safety of Thrice Daily Insulin Aspart Compared to Glibenclamide in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HbA1c
Secondary outcome: Plasma glucose levelsPercentage of subjects achieving the treatment target of HbA1c value < 6.5%
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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 > 7. 5% and <10. 0%
- Body Mass Index (BMI) < 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
Locations and Contacts
Additional Information
Clinical Trials at Novo Nordisk
Starting date: December 2005
Last updated: August 20, 2007
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