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

Randomized，Open-Label，2-Period，Crossover Comparison of Randomized，Open-Label，2-Period，Crossover Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Adult Patients With Type 2 Diabetes Mellitus

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®).

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Diabetes Complications
• Intervention / Treatment: Device: KwikPen® and 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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyuzi Kamoi, MD; Phone Number: +81-0258-28-3600; Email: kkam-int@echigo.ne.jp

Study Locations

• Japan
  • Niigata
    • 2-291 Nagaoka, Niigata, Japan, 940-2085
      • Nagaoka Red Cross Hospital
      • Contact: Kyuzi Kamoi, MD; Phone Number: +81-0258-28-3600; Email: kkam-int@echigo.ne.jp
      • Sub-Investigator: Shinichi Minagawa, MD
      • Sub-Investigator: Keita Kimura, MD
      • Sub-Investigator: Takako Ito, MD
      • Sub-Investigator: Akane Kobayashi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: usability and preference	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nagaoka Red Cross Hospital
• Investigators: Study Director: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 10, 2008
• First Posted (Estimate): December 11, 2008

Study Record Updates

• Last Update Posted (Estimate): December 11, 2008
• Last Update Submitted That Met QC Criteria: December 10, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
• Other Study ID Numbers: 2