A Study for Patients With Diabetes Mellitus (IOPA)

Study Overview
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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.

Official Title
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Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Human insulin 30/70
* Drug: Insulin lispro low mix


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Human insulin mix 30/70 | Drug: Human insulin 30/70<br>* Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks<br>|
| Experimental: 2<br>Insulin lispro low mix | Drug: Insulin lispro low mix<br>* Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks<br>* Other names: Humalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint | Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment. | Baseline and 12 weeks of each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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. | 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. | Baseline and 12 weeks of each treatment | 
| Hypoglycemia Rate Per Participant Per 30 Days | Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment. | over 12 weeks of each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, type 1, type 2