Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Type 2 Diabetic Patients
|ClinicalTrials.gov Identifier: NCT00806975|
Recruitment Status : Unknown
Verified December 2008 by Nagaoka Red Cross Hospital.
Recruitment status was: Not yet recruiting
First Posted : December 11, 2008
Last Update Posted : December 11, 2008
|Condition or disease||Intervention/treatment|
|Diabetes Complications Diabetes Mellitus, Type 2||Device: KwikPen® and FlexPen®|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||June 2009|
|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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806975
|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|