Efficacy of Insulin Lispro Mix 50/50 Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Aichi Gakuin University
Sponsor:
Information provided by:
Aichi Gakuin University
ClinicalTrials.gov Identifier:
NCT01303042
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Insulin lispro mix 50/50

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Aichi Gakuin University:

Primary Outcome Measures:
  • pre- and postprandial glucose levels in SMBG [ Time Frame: nine months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303042

Contacts
Contact: Takahiro Tosaki, MD, PhD +81-52-759-2111 nrd49075@nifty.com

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

No publications provided

Responsible Party: Takahiro Tosaki, Aichi Gakuin University
ClinicalTrials.gov Identifier: NCT01303042     History of Changes
Other Study ID Numbers: AGU-247
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Aichi Gakuin University:
insulin LISPRO
Insulin therapy
hemoglobin A1c protein, human
Blood Glucose Self-Monitoring
Quality of Life
Hypoglycemia
Diabetes Mellitus
1,5-Anhydroglucitol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014