Clinical trial NCT01303042: Efficacy of Insulin Lispro Mix 50/50 Therapy
Official title: Multicenter Trial on Clinical Utility of Insulin Lispro Mix 50/50 T.I.D. Therapy in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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%.

Exclusion Criteria:

* 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

Primary outcomes:
measure: pre- and postprandial glucose levels in SMBG
timeFrame: nine months
Secondary outcomes:
measure: Total score of Questionnaire on QOL
timeFrame: nine months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
state: Aichi
city: Nagoya
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Okazaki
country: Japan
facility: Diabetes Clinic, Okazaki East Hospital
state: Aichi
city: Yokkaichi
country: Japan
facility: Diabetes Center, Yokkaichi Social Insurance Hospital
state: Mie
Study officials:
affiliation: Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
name: Takahiro Tosaki, MD, PhD
role: STUDY_CHAIR
References: