NCT00806975

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nagaoka Red Cross Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-12-11
• Last updated: 2008-12-11

Locations

1 site across 1 country: Japan