A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients (SIMPLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00971997
First received: September 2, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Lispro Mix 50/50
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Study of Stepwise Introduction of Insulin Analog Mixture as a Post-marketing Clinical Trial of Lispro Mix 50/50 to Evaluate Efficacy and Safety in Type 2 Diabetic Patients With Inadequate Glycemic Control on Oral Therapy. (SIMPLE Study)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints [ Time Frame: Week 16 and Week 32 ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.

  • Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints [ Time Frame: Week 16 and Week 32 and Week 48 ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.

  • Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.

  • Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

  • Change From Baseline in Fasting Glucose at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  • Change From Baseline in Blood Glucose Profile at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).

  • Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    C-peptide is a protein that is produced in the body along with insulin.

  • Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight at Week 48 Endpoint [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  • Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48 [ Time Frame: Baseline and Weeks 16, 32 and 48 ] [ Designated as safety issue: No ]
  • Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48 [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
    Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.

  • Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48 [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: No ]
    A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.


Enrollment: 135
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lispro 50/50 Drug: Lispro Mix 50/50
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.
Other Names:
  • LY275585
  • Humalog Mix50

Detailed Description:

A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level. During Study Period I, all the subjects will be given a once daily (QD) injection of lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study Period II) will receive three times daily (TID) injections of insulin.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as having type 2 Diabetes.
  • Patients who have not been on insulin treatment within 6 months.
  • Patients who have been taking OADs for at least 90 days.
  • Patients with an HbA1c level in the range of 7.5% to 11.0%.
  • Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

Exclusion Criteria:

  • Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
  • Patients having or suspected of having malignancy
  • Patients having serious complications of the heart, liver, or kidney.
  • Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
  • Patients receiving systemic steroids.
  • Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
  • Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971997

Locations
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 455-8530
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 277-0832
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 807-0856
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hiroshima, Japan, 738-8503
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, Japan, 051-8501
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyogo, Japan, 658-0064
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ibaraki, Japan, 300-1207
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, Japan, 236-0016
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kumamoto, Japan, 862-0976
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, Japan, 590-0079
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saitama, Japan, 340-0203
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sendai, Japan, 983-0835
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan, 166-0004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yamanashi, Japan, 405-0072
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00971997     History of Changes
Other Study ID Numbers: 13329, F3Z-JE-IOPU
Study First Received: September 2, 2009
Results First Received: March 15, 2012
Last Updated: March 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 16, 2014