A Study for Patients With Diabetes Mellitus (IOPA)

Phase 4CompletedNCT00420095

Eli Lilly and Company117 enrolled

Overview

The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

Human insulin 30/70DRUG

Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks

Insulin lispro low mixDRUG

Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically diagnosed type 1or type 2 diabetes for at least 2 months * Aged between 18 and 70 (inclusive) * Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study * Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1 * Compliance with diet and insulin therapy and performs regular blood glucose monitoring Exclusion Criteria: * Have used oral antidiabetic agents within 30 days prior to entry into the study * Receive a total daily dose of insulin \>2 units/kilogram * Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study * Have a body mass index \>35 kilograms per square meter (kg/m2) * Receive chronic systemic glucocorticoid therapy

Locations (4)

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.

Guangzhou, China

Hangzhou, China

Outcomes

Primary Outcomes

Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint

Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.

Time frame: Baseline and 12 weeks of each treatment

Secondary Outcomes

Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment

Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.

Time frame: Baseline and at 12 weeks of each treatment

Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment

Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint

Time frame: Baseline and 12 weeks of each treatment

Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment

Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint

Time frame: Baseline and 12 weeks of each treatment

Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%

Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.

Time frame: 12 weeks of each treatment

Number of Participants With Laboratory Parameters Significantly Different From Baseline

Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.