Phase 3
Completed N=122
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
Source: ClinicalTrials.gov NCT01474538 ↗Enrolled (actual)
122
Serious AEs
12.2%
Results posted
Mar 2014
Primary outcomePrimary: Glycosylated Hemoglobin A1C (HbA1c) at Endpoint — 7.50; 7.40 percentage of glycosylated hemoglobin
Summary
This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin A1C (HbA1c) at Endpoint |
7.50; 7.40 | — |
| SECONDARY Total Daily Insulin Dose |
80.41; 80.69 | — |
| SECONDARY Rate of Hypoglycemic Events Per 30 Days |
2.24; 2.38 | 0.522 |
| SECONDARY Change From Baseline in Weight |
0.31; 0.89 | 0.216 |
| SECONDARY Percentage of Participants With Hypoglycemic Events |
71.2; 74.8 | 0.471 |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes (per World Health Organization [WHO] Classification of Diabetes)
- Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
- Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
- Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening
- Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
- For participants on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry
Exclusion Criteria
- Have severe insulin resistance [require greater than 2 units/kilogram/day (U/kg/day) of insulin]
- Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
- Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
- Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Data sourced from ClinicalTrials.gov (NCT01474538). 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. Informational only — not medical advice.