A Study for Patients With Diabetes Mellitus (IOPA)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Human insulin mix 30/70

Group Type ACTIVE_COMPARATOR

Human insulin 30/70

Intervention Type DRUG

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

2

Insulin lispro low mix

Group Type EXPERIMENTAL

Insulin lispro low mix

Intervention Type DRUG

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

Interventions

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Human insulin 30/70

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

Intervention Type DRUG

Insulin lispro low mix

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

Intervention Type DRUG

Other Intervention Names

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LM Low Mix Humalog

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No