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Phase 3 Completed N=122 Randomized Triple-blind Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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