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

NCT00806975 | Unknown

• 1 other identifier: 2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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®).

Conditions

Diabetes Complications; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c change rate from the start to 12 and 24 weeks are investigated and compared. Furthermore, using a questionnaire sheet "IDSQ-J" related to the insulin infusion device, the patient's usability and satisfaction with KwikPen® or FlexPen® are performed.

  24 weeks

Secondary Outcomes (1)

• As the secondary endpoints, the incidence of hypoglycemia, changes in body weight (BMI) and blood pressure, and the dose of insulin are investigated and compared before and after the changeover.

  24 weeks

Study Arms (1)

usability and preference

OTHER

Device: KwikPen® and FlexPen®

Interventions

KwikPen® and FlexPen® 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.

usability and preference

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead

Study Sites (1)

Nagaoka Red Cross Hospital

2-291 Nagaoka, Niigata, 940-2085, Japan

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kyuzi Kamoi, MD

  Nagaoka Red Cross Hospital

  STUDY DIRECTOR

Central Study Contacts

Kyuzi Kamoi, MD

CONTACT

+81-0258-28-3600; kkam-int@echigo.ne.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

JP (1)