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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267683

Enrollment

Registered

2005-12-21

Start date

2005-12-31

Completion date

2006-04-30

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief 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.

Interventions

DRUGinsulin aspart

DRUGglibenclamide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 24 weeks of treatment

Secondary

Measure	Time frame
Plasma glucose levels	—
Percentage of subjects achieving the treatment target of HbA1c value < 6.5%	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026