A Study for Type 2 Diabetic Patients

Study Overview
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Brief Summary
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The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Official Title
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Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin lispro low mixture
* Drug: Insulin glargine
* Drug: Insulin lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0% Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications Able to perform self monitoring of blood glucose Exclusion Criteria: Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone) Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks Have a body mass index greater than 35 kg/m2 History or presence of kidney disease Have cardiac disease (Class III or IV)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 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 low mixture<br>Insulin lispro low mixture (1, 2 or 3 daily injections) | Drug: Insulin lispro low mixture<br>* Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.<br>* Other names: LY275585[P];|
| Active Comparator: Insulin glargine<br>Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro) | Drug: Insulin glargine<br>* Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks<br>Drug: Insulin lispro<br>* Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.<br>* Other names: LY275585;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) |  | Baseline, 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c (HbA1c) Over Time |  | Baseline, 16 Weeks, 32 Weeks, 48 Weeks | 
| Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time |  | 16 weeks, 32 weeks, 48 weeks | 
| 7-point Self-monitored Blood Glucose Profiles |  | Baseline, 16 weeks, 32 weeks, 48 weeks | 
| Change From Baseline in Postprandial Blood Glucose Over Time | The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase. | Baseline, 16 weeks, 32 weeks, 48 weeks | 
| Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks |  | 16 weeks, 32 weeks, 48 weeks | 
| Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks |  | 16 weeks, 32 weeks, 48 weeks | 
| Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles |  | baseline, 48 weeks | 
| Safety: Number of Participants With Serious and Non-Serious Adverse Events | Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section. | baseline through 48 weeks |