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

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Lilly

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Lispro Mix 50/50

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971997
F3Z-JE-IOPU (Other Identifier)
13329

Details and patient eligibility

About

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).

Full 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.

Enrollment

135 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

135 participants in 1 patient group

Lispro 50/50
Experimental group
Treatment:
Drug: Lispro Mix 50/50

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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