Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)

Eli Lilly and Company471 enrolled

Overview

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

471

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro Protamine SuspensionDRUG

Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks

Insulin GlargineDRUG

Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have type 2 diabetes mellitus for at least 1 year. * Are greater than or equal to 18 years old. * Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs) * Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2. * Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared. Exclusion Criteria: * Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks. * Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1. * Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. * Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. * Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

Locations (17)

Outcomes

Primary Outcomes

Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)

Time frame: Baseline, 24 Weeks

Secondary Outcomes

Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value

Time frame: Baseline, 12 Weeks, 24 Weeks

Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint

Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.

Time frame: 24 weeks

Glycemic Variability at Endpoint

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.

Time frame: 24 weeks

7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint

Actual measurements and daily mean blood glucose levels at endpoint.

Time frame: 24 weeks

Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall

Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value \<2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.

Time frame: Baseline to 24 weeks

Data from ClinicalTrials.gov

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Jonesboro, Arkansas, United States

Huntington Park, California, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Slidell, Louisiana, United States

Toms River, New Jersey, United States

Brooklyn, New York, United States

...and 7 more locations