Efficacy of Insulin Lispro Mix 50/50 Therapy

NCT01303042 | Unknown DMC

• 1 other identifier: AGU-247
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• pre- and postprandial glucose levels in SMBG

  nine months

Secondary Outcomes (1)

• Total score of Questionnaire on QOL

  nine months

Study Arms (1)

Insulin lispro mix 50/50

EXPERIMENTAL

Drug: Insulin lispro mix 50/50

Interventions

Insulin lispro mix 50/50 DRUG

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

Also known as: Humalog Mix 50/50

Insulin lispro mix 50/50

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aichi Gakuin University: lead

Study Sites (4)

Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University

Nagoya, Aichi-ken, 464-8650, Japan

RECRUITING

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, 468-0009, Japan

NOT YET RECRUITING

Diabetes Clinic, Okazaki East Hospital

Okazaki, Aichi-ken, 444-0008, Japan

RECRUITING

Diabetes Center, Yokkaichi Social Insurance Hospital

Yokkaichi, Mie-ken, 510-0016, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Diabetes Mellitus

Interventions

isophane insulin, insulin lispro drug combination 50:50; insulin lispro, isophane insulin lispro drug combination (25:75)

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Takahiro Tosaki, MD, PhD

  Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University

  STUDY CHAIR

Central Study Contacts

Takahiro Tosaki, MD, PhD

CONTACT

+81-52-759-2111; nrd49075@nifty.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

JP (4)