A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-018664-16-HU
• Date of registration: 02/07/2010
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus
• Scientific title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus
• Date of first enrolment: 16/08/2010
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018664-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Germany, Hungary, Slovakia

Key inclusion & exclusion criteria

Inclusion criteria:
1] Diagnosed with type 1 diabetes (World Health Organization [WHO] criteria) for at least 24 months.
[2] Age >= 13 years.
[3] Treated with CSII therapy for the previous 6 months.
[4] Mean total daily insulin dose for 3 days prior to screening <=46 units (U)/day using a 300-U reservoir or <=26 U/day using a 180–U reservoir.
[5] Baseline body mass index (BMI) <=35.0 kg/m2.
[6] Baseline HbA1c 5% to 9%.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
7] Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study.
[8] Impaired renal function (serum creatinine >=2.0 mg/dL).
[9] Legal blindness.
[10] Have had any episode in previous 12 months prior to Visit 1 of hypoglycemic coma, seizures, or disorientation.
[11] Have had hypoglycemia unawareness (routinely asymptomatic at BG <45 mg/dL) in the 12 months prior to Visit 1.
[12] Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to Visit 1.
[13] Have had a pump-related infusion site abscess in the 12 months prior to Visit 1.
[14] Have had multiple, clinically significant occlusions as judged by the investigator.
[15] Have had any infection with Staphylococcus aureus in the past 5 years.
[16] Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
[17] Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
[18] Have had a blood transfusion or severe blood loss within previous 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
[19] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intra-ocular, and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding Visit 1.
[20] Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night) in the investigator’s opinion.
[21] Have known hypersensitivity or allergy to any of the study insulins or their excipients.
[22] Are breastfeeding or 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.
[23] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[24] Are Lilly employees.
[25] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[26] Have previously completed or withdrawn from this study after having signed the ICD.
[27] Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

type 1 diabetes
MedDRA version: 12.1 Level: LLT Classification code 10067584 Term: Type 1 diabetes mellitus

Intervention(s)

Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Current Sponsor code: LY275585
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Novorapid
Product Name: Novorapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: ? Day 6 of 6D Humalog is noninferior to Day 2 of 6D Humalog with regards to mean SMBG (margin = 0.6 mmol/L)
? Compare 6D Humalog to 6D insulin aspart with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, hyperglycemic events, adverse events (AEs), and HbA1c
? Compare Days 1 through 6 of 6D Humalog to Days 1 through 6 of 6D insulin aspart individually and cumulatively with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events
? Compare Days 1 through 3 with Days 4 through 6 individually and cumulatively of 6D Humalog and 6D insulin aspart, between and within treatment groups with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events
? Compare Days 1 and 2 with Days 4 and 5 of 6D Humalog and 6D insulin aspart between and within treatment groups with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events

Primary end point(s): 1. Day 6 of 6 days (6D) of pump reservoir in-use of Humalog is noninferior to Day 6 of 6D of pump reservoir in-use of insulin aspart with regards to 7-point daily mean SMBG (with margin of 06. mmol/L)
2. Day 6 of 6D of pump reservoir in-use of Humalog is superior to Day 6 of 6D of pump reservoir in-use of insulin aspart with regards to 7-point daily mean SMBG.

Main Objective: 1. Day 6 of 6 days (6D) of pump reservoir in-use of Humalog is noninferior to Day 6 of 6D of pump reservoir in-use of insulin aspart with regards to 7-point daily mean SMBG (with a margin of 0.6 mmol/L)
2. Day 6 of 6D of pump reservoir in-use of Humalog is superior to Day 6 of 6D of pump reservoir in-use of insulin apart with regards to 7-point daily mean SMBG

Secondary ID(s)

2010-018664-16-DE

F3Z-MC-IOPW