Phase 3
N=471
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00510952 ↗Enrolled (actual)
471
Serious AEs
3.1%
Results posted
Nov 2009
Primary outcome: Primary: Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) — 8.70; 8.69; -1.46; -1.41 percent of HbA1c — p=0.551
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin Lispro Protamine Suspension (Drug); Insulin Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) |
8.70; 8.69; -1.46; -1.41 | 0.551 |
| SECONDARY Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value |
8.70; 8.69; 7.30; 7.36; -1.36; -1.30 | 0.427 |
| SECONDARY Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint |
43.8; 41.2; 24.8; 21.7 | 0.634 |
| SECONDARY Glycemic Variability at Endpoint |
1.01; 0.94 | 0.323 |
| SECONDARY 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint |
6.47; 6.33; 8.64; 9.00; 6.93; 7.16 | 0.302 |
| SECONDARY Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall |
168; 160; 114; 87; 9; 2 | 0.468 |
| SECONDARY 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall |
24.16; 22.95; 6.08; 4.08; 0.11; 0.02 | 0.316 |
| SECONDARY 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall |
1.98; 1.88; 0.50; 0.34; 0.01; 0.00 | — |
| SECONDARY Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint |
84.23; 86.05; 1.04; 1.07 | 0.975 |
| SECONDARY Total Daily Insulin Dose (Units) at Endpoint |
33.28; 30.85 | 0.031 sig |
| SECONDARY Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint |
0.39; 0.35 | 0.015 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00510952). 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.