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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Nagaoka Red Cross Hospital

December 9, 2008
December 11, 2008
December 11, 2008
January 2009
June 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
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®).
  • 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
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Complications
  • Diabetes Mellitus, Type 2
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.
usability and preference
Intervention: Device: KwikPen® and FlexPen®
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Kyuzi Kamoi, Nagaoka Red Cross Hospital
Nagaoka Red Cross Hospital
Not Provided
Study Director: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
Nagaoka Red Cross Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP