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

NCT ID: NCT00806975

Last Updated: 2008-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

Brief 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®).

Detailed Description

• Concomitant drugs The treatment with other insulin preparation is prohibited during the study period. As to the drugs except insulin that have been used for the treatment of diabetes and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. If any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator.
• Compliance with treatment method The investigator gives sufficient explanation on the following contents to the patient.

• To inject the prescribed volume of insulin at the prescribed time.
• To observe the appointed date for the next visit.
• Termination of assessment The study is discontinued if any of the following events occurs after the start of study.

• Important protocol violation
• When continued treatment is judged difficult due to the onset of an adverse event
• Death
• When the follow-up of patient becomes impossible
• Other than the above, when the investigator judges it necessary to discontinue the study

Conditions

Diabetes Complications; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

usability and preference

Group Type: OTHER

KwikPen® and FlexPen®

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes mellitus patients
• Patients who have used Humalog Mix 25 injection KwikPen® or Novo Rapid 30 Mix injection FlexPen® for 3 months or more.
• Outpatients regularly visiting hospital
• Patients 20 years old or older but under 80 years old (gender is disregarded)

Exclusion Criteria

• Patients with a serious complication in the heart, liver or kidney
• Pregnant or possibly pregnant patients, or lactating patients
• Patients complicated with a malignant tumor at present.
• Patients allergic to insulin analog preparations.
• Patients taking an illegal drug.
• Patients participating in other clinical study.
• Other than the above, patients judged inappropriate as the subjects of this study by the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nagaoka Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nagaoka Red Cross Hospital

Principal Investigators

Kyuzi Kamoi, MD

Role: STUDY_DIRECTOR

Nagaoka Red Cross Hospital

Locations

Nagaoka Red Cross Hospital

2-291 Nagaoka, Niigata, Japan

Countries

Japan

Central Contacts

Kyuzi Kamoi, MD

Role: CONTACT

kkam-int@echigo.ne.jp

+81-0258-28-3600

Facility Contacts

Kyuzi Kamoi, MD

Role: primary

kkam-int@echigo.ne.jp

+81-0258-28-3600

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id