Efficacy of Insulin Lispro Mix 50/50 Therapy
Recruitment status was: Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Trial on Clinical Utility of Insulin Lispro Mix 50/50 T.I.D. Therapy in Patients With Type 2 Diabetes Mellitus|
- pre- and postprandial glucose levels in SMBG [ Time Frame: nine months ] [ Designated as safety issue: Yes ]
- Total score of Questionnaire on QOL [ Time Frame: nine months ] [ Designated as safety issue: Yes ]Secondary end points include change in HbA1c and rates of hypoglycemia.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Insulin lispro mix 50/50||
Drug: Insulin lispro mix 50/50
Insulin lispro mix 50/50 t.i.d : six months
Other Name: Humalog Mix 50/50
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303042
|Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University|
|Nagoya, Aichi, Japan, 464-8650|
|Tosaki Clinic for Diabetes and Endocrinology|
|Nagoya, Aichi, Japan, 468-0009|
|Diabetes Clinic, Okazaki East Hospital|
|Okazaki, Aichi, Japan, 444-0008|
|Diabetes Center, Yokkaichi Social Insurance Hospital|
|Yokkaichi, Mie, Japan, 510-0016|
|Study Chair:||Takahiro Tosaki, MD, PhD||Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University|