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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Nagaoka Red Cross Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT00806975
First received: December 9, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

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®).


Condition Intervention
Diabetes Complications
Diabetes Mellitus, Type 2
Device: KwikPen® and FlexPen®

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
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)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806975

Contacts
Contact: Kyuzi Kamoi, MD +81-0258-28-3600 kkam-int@echigo.ne.jp

Locations
Japan
Nagaoka Red Cross Hospital Not yet recruiting
2-291 Nagaoka, Niigata, Japan, 940-2085
Contact: Kyuzi Kamoi, MD    +81-0258-28-3600    kkam-int@echigo.ne.jp   
Sub-Investigator: Shinichi Minagawa, MD         
Sub-Investigator: Keita Kimura, MD         
Sub-Investigator: Takako Ito, MD         
Sub-Investigator: Akane Kobayashi, MD         
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
Study Director: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
  More Information

No publications provided

Responsible Party: Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT00806975     History of Changes
Other Study ID Numbers: 2
Study First Received: December 9, 2008
Last Updated: December 10, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014