Diabetes ComplicationsNCT00806975
Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Type 2 Diabetic Patients
A study testing KwikPen® and FlexPen® in people with Diabetes Complications and Diabetes Mellitus, Type 2, run by Nagaoka Red Cross Hospital at 1 site in Japan.
Trial 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®). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Complications, Diabetes Mellitus, Type 2
- What is being tested?
- KwikPen® and FlexPen®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Nagaoka Red Cross Hospital
2-291 Nagaoka, Niigata, 940-2085
Kyuzi Kamoi, MD, +81-0258-28-3600, kkam-int@echigo.ne.jp
Shinichi Minagawa, MD
About this study
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
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®).
Read the 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
- Being tested
- KwikPen® and FlexPen®
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KwikPen® and FlexPen®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| usability and preference | Other | Not described Receives: Device: KwikPen® and FlexPen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (1)
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagaoka Red Cross Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyuzi Kamoi, MD, Study director, Nagaoka Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806975
- Sponsor's protocol ID
- 2
- Status last verified
- Dec 2008
- First submitted
- 9 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00806975
- Acronym / sponsor ID
- 2
- Conditions
- Diabetes Complications, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nagaoka Red Cross HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| usability and preference | Other | Device: KwikPen® and FlexPen® |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | usability and preference |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyuzi Kamoi, MD study director
Nagaoka Red Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KwikPen® and FlexPen® in people with Diabetes Complications and Diabetes Mellitus, Type 2, run by Nagaoka Red Cross Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyuzi Kamoi, MD (+81-0258-28-3600, kkam-int@echigo.ne.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.