Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Type 2 Diabetic Patients
Recruitment status was Not yet recruiting
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®).
Diabetes Mellitus, Type 2
Device: KwikPen® and FlexPen®
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|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.
- 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
- When the follow-up of patient becomes impossible
- Other than the above, when the investigator judges it necessary to discontinue the study
|Contact: Kyuzi Kamoi, MDfirstname.lastname@example.org|
|Nagaoka Red Cross Hospital||Not yet recruiting|
|2-291 Nagaoka, Niigata, Japan, 940-2085|
|Contact: Kyuzi Kamoi, MD +81-0258-28-3600 email@example.com|
|Sub-Investigator: Shinichi Minagawa, MD|
|Sub-Investigator: Keita Kimura, MD|
|Sub-Investigator: Takako Ito, MD|
|Sub-Investigator: Akane Kobayashi, MD|
|Study Director:||Kyuzi Kamoi, MD||Nagaoka Red Cross Hospital|