Type 1
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: IU/ml international unit(s)/millil
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the study, patients had to be 13 years or older, diagnosed with T1DM (World Health Organization criteria) for at least 24 months with HbA1c between 5% and 9% and body mass index (BMI) ?35.0 kg/m2 at baseline. Patients had to be using CSII therapy for at least the 6 months prior to Visit 1 with mean total daily insulin dose for 3 days prior to Visit 1 of ?46 units (U)/day using a 300-U reservoir, ?30 U/day using a 200-U reservoir, or ?26 U/day using 180-U reservoir. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Patients were excluded from participation in the study if they have had impaired renal function; legal blindness; an episode of hypoglycemia coma, seizures or disorientation, hypoglycemic unawareness; emergency room visits or hospitalizations due to poor glucose control; pump-related infusion site abscess in the 12 months prior to Visit 1; or a history of a staphylococcus aureus infection in the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Day 6 of 6 days of pump reservoir in-use of Humalog 6D was noninferior to Day 6 of 6 days of pump reservoir in-use of Aspart 6D with regards to 7-point daily mean self-monitored blood glucose (SMBG; margin = 0.6 mmol/L). 2) Day 6 of 6 days of pump reservoir in-use of Humalog 6D was noninferior to Day 2 of 2 days of pump reservoir in-use of Humalog 2D with regards to 7-point daily mean SMBG (margin = 0.6 mmol/L). 3)Day 6 of 6 days of pump reservoir in-use of Humalog 6D was superior to Day 6 of 6 days of pump reservoir in-use of Aspart 6D with regards to 7-point daily mean SMBG.;Secondary Objective: - compare Humalog 6D to Aspart 6D at various time points with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, hyperglycemic events, adverse events (AEs), and hemoglobin A1c (HbA1c); ;Primary end point(s): HbA1C ;Timepoint(s) of evaluation of this end point: Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HbA1C;Timepoint(s) of evaluation of this end point: Day 6 | — |
Countries
United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed