Efficacy of Insulin Lispro Mix 50/50 Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin lispro mix 50/50

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Takahiro Tosaki, MD, PhD; Phone Number: +81-52-759-2111; Email: nrd49075@nifty.com

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 464-8650
      • Recruiting
      • Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
      • Contact: Takahiro Tosaki, MD, PhD; Phone Number: +81-52-759-2111; Email: nrd49075@nifty.com
      • Principal Investigator: Takahiro Tosaki, MD, PhD
      • Sub-Investigator: Keiko Naruse, MD, PhD
    • Nagoya, Aichi, Japan, 468-0009
      • Not yet recruiting
      • Tosaki Clinic for Diabetes and Endocrinology
      • Principal Investigator: Takahiro Tosaki, MD, PhD
      • Contact: Takahiro Tosaki, MD, PhD; Email: nrd49075@nifty.com
    • Okazaki, Aichi, Japan, 444-0008
      • Recruiting
      • Diabetes Clinic, Okazaki East Hospital
      • Principal Investigator: Takahiro Tosaki, MD, PhD
      • Contact: Takahiro Tosaki, MD, PhD; Phone Number: +81-564-22-6616; Email: nrd49075@nifty.com
      • Sub-Investigator: Chizuko Suzuki, MD, PhD
      • Sub-Investigator: Maiko Mizutani, MD, PhD
  • Mie
    • Yokkaichi, Mie, Japan, 510-0016
      • Recruiting
      • Diabetes Center, Yokkaichi Social Insurance Hospital
      • Principal Investigator: Takahiro Tosaki, MD, PhD
      • Contact: Takahiro Tosaki, MD, PhD; Phone Number: +81-59-331-2000; Email: nrd49075@nifty.com
      • Sub-Investigator: Miho Miyoshi, MD
      • Sub-Investigator: Tomoki Majima, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin lispro mix 50/50	Drug: Insulin lispro mix 50/50; Insulin lispro mix 50/50 t.i.d : six months; Other Names: Humalog Mix 50/50

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pre- and postprandial glucose levels in SMBG	nine months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of Questionnaire on QOL	Secondary end points include change in HbA1c and rates of hypoglycemia.	nine months

Collaborators and Investigators

• Sponsor: Aichi Gakuin University
• Investigators: Study Chair: Takahiro Tosaki, MD, PhD, Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Hypoglycemia; Quality of Life; Diabetes Mellitus; Blood Glucose Self-Monitoring; hemoglobin A1c protein, human; Insulin therapy; insulin LISPRO; 1,5-Anhydroglucitol
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro; Isophane insulin, insulin lispro drug combination 50:50
• Other Study ID Numbers: AGU-247