Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin lispro mid mixture (MM)Drug: Insulin glargine
- Registration Number
- NCT00377858
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 484
- 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%.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Lispro Mid Mixture Insulin lispro mid mixture (MM) Insulin lispro mid mixture (MM) up to three times a day (TID) Insulin Glargine Insulin glargine Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
- Primary Outcome Measures
Name Time Method Hemoglobin A1c (HbA1c) at 36 Week Endpoint 36 weeks Level of hemoglobin A1c at endpoint.
- Secondary Outcome Measures
Name Time Method Hemoglobin A1c (HbA1c) at Interval Visits 12, 24, and 36 weeks Levels of HbA1c at 12 weeks and 24 weeks 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 12-24-36 weeks 7-point Self-monitored Blood Glucose Profiles Baseline, 12-24-36 weeks Actual daily mean blood glucose levels at specified time points.
Glycemic Variability Baseline, 12-24-36 weeks 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.
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia Baseline to 36 Weeks 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.
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) Baseline to 36 Weeks 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.
Number of Patients With at Least One Severe Hypoglycemia Episode Baseline to 36 Weeks 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.
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial 36 Weeks 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.
Endpoint Insulin Dose; Total, Basal, and Prandial 36 Weeks 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.
Number of Insulin Injections Per Day Weeks 12, 24, 30, 36 Change From Baseline in Absolute Body Weight at 36 Week Endpoint Baseline, 36 Weeks Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇪🇸Malaga, Spain