MedTrace Logo

Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Type 2 Diabetic Patients

NCT00806975 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-12-11

No results posted yet for this study

Summary

The purpose of this study is to investigate patient's usability, preference and blood glucose control for the new prefilled disposable insulin lispro mixture (Humalog Mix 25 injection KwikPen®). For that purpose, randomized open-label, 2-period direct comparative crossover study is planned in comparison with insulin aspart mixture (Novo Rapid 30 Mix injection FlexPen®).

Conditions

  • Diabetes Complications
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

KwikPen® and FlexPen®

The treatment is changed to twice a day injection of the same unit of Novo Rapid 30 Mix injection FlexPen® or Humalog Mix 25 injection KwikPen®for 3 months, after which the final assessment is made.

Sponsors & Collaborators

  • Nagaoka Red Cross Hospital

    lead OTHER

Principal Investigators

  • Kyuzi Kamoi, MD · Nagaoka Red Cross Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Japan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806975 on ClinicalTrials.gov