A Study for Patients With Diabetes Mellitus (IOPA)

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin lispro low mix; Drug: Human insulin 30/70

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420095

11423

F3Z-GH-IOPA

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

1

Active Comparator group

Description:

Human insulin mix 30/70

Treatment:

Drug: Human insulin 30/70

2

Experimental group

Description:

Insulin lispro low mix

Treatment:

Drug: Insulin lispro low mix