A study to compare an investigational ultra-rapid insulin LY900014 with Humalog given by insulin pump in people with type 1 diabetes.

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-005358-36-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-11
• Study Completion: 2020-01-06
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

•Men or women diagnosed (clinically) with T1D for at least 1 year prior to screening, and continuously using insulin for at least 1 year
•Are at least 18 years of age
•Have been using CSII therapy for a minimum of 6 months prior to screening. Interruption of CSII is allowed during the 6 months prior to screening for up to a total of 14 days, such as during a hospitalization, a pump malfunction, or a pump holiday”
•Must be using a MiniMed 530G or 630G (US), 640G (EU), insulin pump for at least the last 90 days and willing to stay on the same pump throughout the study
•Are willing to maintain their current bolus delivery speed (standard or quick) for the duration of the study
•Have HbA1c values of =6.5 and =9.0%, as determined by the central laboratory at screening (Visit 1)
•Have a body mass index (BMI) of =35.0 kg/m2 at screening (Visit 1)
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol
-Have hypoglycemia unawareness as judged by the investigator
-Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening
-Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or DKA) within 6 months prior to screening
-Have cardiovascular disease, within the last 6 months prior to screening, defined as stroke, decompensated heart failure New York Heart Association class III or IV (CCNYHA 1994), myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary arterial bypass graft

Renal:
a.History of renal transplantation
b.Currently receiving renal dialysis
c.Serum creatinine >2.0 mg/dL (177 µmol/L) at screening, or
d.An estimated glomerular filtration rate of <30 mL/min/1.73 m2.

-Hepatic: have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis), or elevated liver enzyme measurements as indicated below at screening
a.Total bilirubin level (TBL) =2X the upper limit of normal (ULN) (with the exception of Gilberts Disease) as defined by the central laboratory,
Or
b.Alanine aminotransferase (ALT) =3X ULN as defined by the central laboratory,
Or
c.Aspartate aminotransferase (AST) =3X ULN as defined by the central laboratory

-Hematologic: have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia that is clinically significant based on investigator judgement, or any other traits of known to interfere with measurement of HbA1c
-Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations; includes those with gastric bypass) in the opinion of investigator
-Have significant lipohypertrophy, lipoatrophy, or scars within the SC tissue in areas of infusion, in the opinion of the investigator
-Have a history of abscess at an infusion site within the last 90 days prior to screening
-Have vision loss or hearing loss that does not allow recognition of pump screens, alerts and alarms

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified