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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00806975
• Other study ID #: 2
• Status: Not yet recruiting
• Phase: N/A
• First received: December 9, 2008
• Last updated: December 10, 2008
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: December 2008
• Source: Nagaoka Red Cross Hospital
• Contact: Kyuzi Kamoi, MD
• Phone: +81-0258-28-3600
• Email: kkam-int[@]echigo.ne.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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®).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Japan	Nagaoka Red Cross Hospital	2-291 Nagaoka	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Nagaoka Red Cross Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes