Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

Eli Lilly and Company484 enrolled

Overview

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

484

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin lispro mid mixture (MM)DRUG

Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

Insulin glargineDRUG

Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have type 2 diabetes * Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label * Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%. Exclusion Criteria: * Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label. * Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion. * 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 40 kg/m2. * Have had more than one episode of severe hypoglycemia in the last24 weeks * Are pregnant, intend to be pregnant during the course of the study or are breastfeeding * Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease

Locations (25)

Outcomes

Primary Outcomes

Hemoglobin A1c (HbA1c) at 36 Week Endpoint

Level of hemoglobin A1c at endpoint.

Time frame: 36 weeks

Secondary Outcomes

Hemoglobin A1c (HbA1c) at Interval Visits

Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.

Time frame: 12, 24, and 36 weeks

Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint

Time frame: 12-24-36 weeks

7-point Self-monitored Blood Glucose Profiles

Actual daily mean blood glucose levels at specified time points.

Time frame: Baseline, 12-24-36 weeks

Glycemic Variability

Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.

Time frame: Baseline, 12-24-36 weeks

Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia

Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

Data from ClinicalTrials.gov

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Keswick, South Australia, Australia

Fitzroy, Victoria, Australia

Fremantle, Western Australia, Australia

London, Ontario, Canada

Granby, Quebec, Canada

Sherbrooke, Quebec, Canada

Regina, Saskatchewan, Canada

Mantes-la-Jolie, France

Menton, France

Pau, France

...and 15 more locations

Time frame: Baseline to 36 Weeks

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)

Time frame: Baseline to 36 Weeks

Number of Patients With at Least One Severe Hypoglycemia Episode

Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

Time frame: Baseline to 36 Weeks

Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial

Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \[U/kg/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

Time frame: 36 Weeks

Endpoint Insulin Dose; Total, Basal, and Prandial

Total daily insulin dose (Units of insulin per day \[U/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

Time frame: 36 Weeks

Number of Insulin Injections Per Day

Time frame: Weeks 12, 24, 30, 36

Change From Baseline in Absolute Body Weight at 36 Week Endpoint

Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.

Time frame: Baseline, 36 Weeks