A Study for Type 2 Diabetic Patients

Eli Lilly and Company426 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

426

Conditions

Type 2 Diabetes Mellitus

Interventions

Insulin lispro low mixtureDRUG

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.

Insulin glargineDRUG

Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks

Insulin lisproDRUG

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)

Locations (25)

Outcomes

Primary Outcomes

Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

Time frame: Baseline, 48 weeks

Secondary Outcomes

Change in Hemoglobin A1c (HbA1c) Over Time

Time frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks

Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time

Time frame: 16 weeks, 32 weeks, 48 weeks

7-point Self-monitored Blood Glucose Profiles

Time frame: 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.

Time frame: Baseline, 16 weeks, 32 weeks, 48 weeks

Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks

Time frame: 16 weeks, 32 weeks, 48 weeks

Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks

Time frame: 16 weeks, 32 weeks, 48 weeks

Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles

Time frame: 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.

Data from ClinicalTrials.gov

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Daw Park, South Australia, Australia

East Ringwood, Victoria, Australia

Nedlands, Western Australia, Australia

Belém, Brazil

Campinas, Brazil

Curitiba, Brazil

Fortaleza, Brazil

Edmonton, Alberta, Canada

Winnipeg, Manitoba, Canada

Mississauga, Ontario, Canada

...and 15 more locations