Comparison of Insulin Mix25 Versus Mix50

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).

Official Title
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Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Lispro Mix25
* Drug: Insulin Lispro Mix50


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²) Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site Exclusion Criteria: Have a diagnosis of type 1 diabetes Have had more than 1 episode of severe hypoglycemia within the 6 months before screening Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke) Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Lispro Mix25<br>Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks. | Drug: Insulin Lispro Mix25<br>* Administered SC<br>* Other names: LY275585-75;|
| Experimental: Insulin Lispro Mix50<br>Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks. | Drug: Insulin Lispro Mix50<br>* Administered SC<br>* Other names: LY275585-50;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 | HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect. | Baseline, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26 | HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100. | Baseline through Week 26 | 
| Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 | LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect. | Baseline, Week 26 | 
| Change From Baseline in Body Weight at Week 26 | LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect. | Baseline, Week 26 | 
| Number of Hypoglycemic Events Baseline Through Week 26 (Incidence) | A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. | Baseline through Week 26 | 
| Insulin Dose at Week 26 | Insulin dose is the total daily dose including basal and prandial doses. | Week 26 | 
| Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 | LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect. | Baseline, Week 26 |