Phase 4
N=484
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00377858 ↗Enrolled (actual)
484
Serious AEs
4.6%
Results posted
Dec 2009
Primary outcome: Primary: Hemoglobin A1c (HbA1c) at 36 Week Endpoint — 7.66; 7.49 percent HbA1c — p=0.097
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin lispro mid mixture (MM) (Drug); Insulin glargine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) at 36 Week Endpoint |
7.66; 7.49 | 0.097 |
| SECONDARY Hemoglobin A1c (HbA1c) at Interval Visits |
8.02; 7.85; 7.53; 7.36; 7.53; 7.44 | 0.047 sig |
| SECONDARY 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 |
21.2; 25.2; 78.8; 74.8; 18.9; 21.6 | 0.432 |
| SECONDARY 7-point Self-monitored Blood Glucose Profiles |
10.22; 9.64; 12.49; 12.39; 10.15; 9.62 | 0.014 sig |
| SECONDARY Glycemic Variability |
2.09; 2.07; 48.02; 46.75; 1.51; 1.54 | 0.776 |
| SECONDARY Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia |
87; 106; 178; 179; 30; 37 | 0.094 |
| SECONDARY 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) |
1.57; 2.19; 1.88; 2.21; 0.26; 0.32 | 0.022 sig |
| SECONDARY Number of Patients With at Least One Severe Hypoglycemia Episode |
1; 1; 8; 5 | 0.416 |
| SECONDARY Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial |
0.27; 0.35; 0.36; 0.29; 0.57; 0.51 | <0.001 sig |
| SECONDARY Endpoint Insulin Dose; Total, Basal, and Prandial |
19.90; 26.86; 27.73; 21.68; 43.44; 38.25 | <0.001 sig |
| SECONDARY Number of Insulin Injections Per Day |
1.33; 1.00; 1.97; 1.76; 2.05; 1.81 | <0.001 sig |
| SECONDARY Change From Baseline in Absolute Body Weight at 36 Week Endpoint |
76.71; 77.00; 3.09; 3.19 | 0.803 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00377858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.