Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2011-02-28
2014-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Insulin lispro mix 50/50
Insulin lispro mix 50/50
Insulin lispro mix 50/50 t.i.d : six months
Interventions
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Insulin lispro mix 50/50
Insulin lispro mix 50/50 t.i.d : six months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Aichi Gakuin University
OTHER
Responsible Party
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Aichi Gakuin University
Principal Investigators
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Takahiro Tosaki, MD, PhD
Role: STUDY_CHAIR
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Locations
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Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Nagoya, Aichi-ken, Japan
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, Japan
Diabetes Clinic, Okazaki East Hospital
Okazaki, Aichi-ken, Japan
Diabetes Center, Yokkaichi Social Insurance Hospital
Yokkaichi, Mie-ken, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AGU-247
Identifier Type: -
Identifier Source: org_study_id
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