Efficacy of Insulin Lispro Mix 50/50 Therapy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Multicenter Trial on Clinical Utility of Insulin Lispro Mix 50/50 T.I.D. Therapy in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01303042
• Other study ID #: AGU-247
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2011
• Last updated: February 23, 2011
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2011
• Source: Aichi Gakuin University
• Contact: Takahiro Tosaki, MD, PhD
• Phone: +81-52-759-2111
• Email: nrd49075[@]nifty.com
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin lispro mix 50/50
Insulin lispro mix 50/50 t.i.d : six months

Locations

Country	Name	City	State
Japan	Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University	Nagoya	Aichi
Japan	Tosaki Clinic for Diabetes and Endocrinology	Nagoya	Aichi
Japan	Diabetes Clinic, Okazaki East Hospital	Okazaki	Aichi
Japan	Diabetes Center, Yokkaichi Social Insurance Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre- and postprandial glucose levels in SMBG		nine months	Yes
Secondary	Total score of Questionnaire on QOL	Secondary end points include change in HbA1c and rates of hypoglycemia.	nine months	Yes