Diabetes Mellitus, Type 2NCT01303042
Efficacy of Insulin Lispro Mix 50/50 Therapy
A study testing Insulin lispro mix 50/50 in people with Diabetes Mellitus, Type 2, run by Aichi Gakuin University at 4 sites in Japan.
Trial summary
Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The management is comparatively simple and easy, but the curative effect is promising. It is also reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial premixed therapy (PPT, lispro mix… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin lispro mix 50/50
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesJapan
- Study dates
- Feb 2011to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients who are treated with insulin basal/bolus therapy ( long-acting insulin at bedtime and mealtime rapid-acting insulin ) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) and whose HbA1c is above 7.4%.
Who cannot join
- Patients with renal failure with serum creatinine level ≧ 2.0
- Patients with hepatocirrhosis
- Patients with proliferative diabetic retinopathy or worse
- Patients with acute infectious disease
- Patients who are treated with steroids
- Patients with cancer
- Pregnant patients
- Patients who are decided to be inappropriate subjects by study physicians
Trial locations and contacts
4 sites in 1 country.
Japan4 sites, 4 recruiting
- Recruiting
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Nagoya, Aichi-ken, 464-8650
Takahiro Tosaki, MD, PhD, +81-52-759-2111, nrd49075@nifty.com
Takahiro Tosaki, MD, PhD
- Not yet recruiting
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, 468-0009
Takahiro Tosaki, MD, PhD, nrd49075@nifty.com
Takahiro Tosaki, MD, PhD
- Recruiting
Diabetes Clinic, Okazaki East Hospital
Okazaki, Aichi-ken, 444-0008
Takahiro Tosaki, MD, PhD, +81-564-22-6616, nrd49075@nifty.com
Chizuko Suzuki, MD, PhD
- Recruiting
Diabetes Center, Yokkaichi Social Insurance Hospital
Yokkaichi, Mie-ken, 510-0016
Takahiro Tosaki, MD, PhD, +81-59-331-2000, nrd49075@nifty.com
Miho Miyoshi, MD
About this study
Official title: Multicenter Trial on Clinical Utility of Insulin Lispro Mix 50/50 T.I.D. Therapy in Patients With Type 2 Diabetes Mellitus
Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The management is comparatively simple and easy, but the curative effect is promising. It is also reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial premixed therapy (PPT, lispro mix 50/50 t.i.d.).
The purpose of this study is to evaluate whether change of insulin therapy from BBT (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50 t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.
Read the detailed description
Patients will continue existing insulin therapy for three months. After that, the investigators will change insulin therapy according to the insulin regimen below and continue the therapy for six months.
Patients will terminate from sulfonylurea treatment at the change of insulin therapy. The investigators will not change other oral hypoglycemic agents during the whole study period.
Regimen: Divide the total units of all insulin per day by three and equally apply the amount to mealtime injections of insulin lispro mix 50/50 t.i.d. When the unit is indivisible and the remainder is one unit, add it to the mealtime injection of breakfast. When the remainder is two units, add each unit to mealtime injections of breakfast and dinner.
Patients will terminate from the trial when their HbA1c increases by 1% and stays at the level for more than three months after the change of insulin regimen.
When there is a risk of hypoglycemia at the change of insulin regimen, the investigators will divide ninety percent of the total insulin units per day by three and equally apply the amount to mealtime injections of insulin lispro 50/50. When considered to be safe, the investigators will increase the insulin unit per day to the total insulin unit at the previous treatment within two months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin lispro mix 50/50
- Keywords
- insulin LISPRO, Insulin therapy, hemoglobin A1c protein, human, Blood Glucose Self-Monitoring, Quality of Life, Hypoglycemia, Diabetes Mellitus, 1,5-Anhydroglucitol
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin lispro mix 50/50Drug
Also called Humalog Mix 50/50
Insulin lispro mix 50/50 t.i.d : six months
| Study group | Role | What they receive |
|---|---|---|
| Insulin lispro mix 50/50 | Experimental | Not described Receives: Drug: Insulin lispro mix 50/50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre- and postprandial glucose levels in SMBG
Measured: nine months
Secondary outcomes (1)
Total score of Questionnaire on QOL
Secondary end points include change in HbA1c and rates of hypoglycemia.
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Gakuin University
- Sponsor type
- University, hospital or other
- Investigators
- Takahiro Tosaki, MD, PhD, Study chair, Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303042
- Sponsor's protocol ID
- AGU-247
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial on Clinical Utility of Insulin Lispro Mix 50/50 T.I.D. Therapy in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01303042
- Acronym / sponsor ID
- AGU-247
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- insulin LISPRO, Insulin therapy, hemoglobin A1c protein, human, Blood Glucose Self-Monitoring, Quality of Life, Hypoglycemia, Diabetes Mellitus, 1,5-Anhydroglucitol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aichi Gakuin UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 2011 (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.
Insulin therapy with lispro mix 50/50 t.i.d. is a treatment with a single insulin device. The management is comparatively simple and easy, but the curative effect is promising. It is also reported that noninferiority has been observed between basal/bolus therapy (BBT) and prandial premixed therapy (PPT, lispro mix 50/50 t.i.d.).
The purpose of this study is to evaluate whether change of insulin therapy from BBT (long-acting insulin at bedtime plus mealtime rapid-acting insulin) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) to lispro mix 50/50 t.i.d. improves glycemic control of patients with type 2 diabetes mellitus.
Detailed description
Patients will continue existing insulin therapy for three months. After that, the investigators will change insulin therapy according to the insulin regimen below and continue the therapy for six months.
Patients will terminate from sulfonylurea treatment at the change of insulin therapy. The investigators will not change other oral hypoglycemic agents during the whole study period.
Regimen: Divide the total units of all insulin per day by three and equally apply the amount to mealtime injections of insulin lispro mix 50/50 t.i.d. When the unit is indivisible and the remainder is one unit, add it to the mealtime injection of breakfast. When the remainder is two units, add each unit to mealtime injections of breakfast and dinner.
Patients will terminate from the trial when their HbA1c increases by 1% and stays at the level for more than three months after the change of insulin regimen.
When there is a risk of hypoglycemia at the change of insulin regimen, the investigators will divide ninety percent of the total insulin units per day by three and equally apply the amount to mealtime injections of insulin lispro 50/50. When considered to be safe, the investigators will increase the insulin unit per day to the total insulin unit at the previous treatment within two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin lispro mix 50/50 | Experimental | Drug: Insulin lispro mix 50/50 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes patients who are treated with insulin basal/bolus therapy ( long-acting insulin at bedtime and mealtime rapid-acting insulin ) or analog insulin therapy t.i.d. (including therapies with aspart mix 70/30 and lispro mix 75/25) and whose HbA1c is above 7.4%.
Key exclusion criteria (8 listed)
- Patients with renal failure with serum creatinine level ≧ 2.0
- Patients with hepatocirrhosis
- Patients with proliferative diabetic retinopathy or worse
- Patients with acute infectious disease
- Patients who are treated with steroids
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 |
|---|---|---|
| Insulin lispro mix 50/50Also: Humalog Mix 50/50Insulin lispro mix 50/50 t.i.d : six months | Drug | Insulin lispro mix 50/50 |
Primary outcome
pre- and postprandial glucose levels in SMBG
Time frame: nine months
1 secondary outcome
Total score of Questionnaire on QOL
Time frame: nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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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.
Takahiro Tosaki, MD, PhD study chair
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin lispro mix 50/50 in people with Diabetes Mellitus, Type 2, run by Aichi Gakuin University at 4 sites 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 1 inclusion and 8 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 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Takahiro Tosaki, MD, PhD (+81-52-759-2111, nrd49075@nifty.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre- and postprandial glucose levels in SMBG (time frame: nine months). 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 24 Feb 2011.