Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability
      and efficacy study
    

Detailed description: 
      This is a double blind, active comparator controlled multiple dose safety, tolerability and
      efficacy study comparing HDV insulin lispro with insulin lispro in 40 Type 1 Diabetes
      Mellitus Subjects with Good Glycemic Control, with specific focus on time in range (70-180
      mg/dL). Subjects will be screened and then monitored with one week of baseline CGM. They will
      then be randomized to one of two treatment groups: (A) six weeks of treatment with HDV-lispro
      (B) six weeks of treatment with insulin lispro diluted with sterile water alone.

      All subjects will use insulin glargine or insulin degludec for basal insulin coverage
      throughout the trial. Fasting glucose goals will be 70-120 mg/dL, with recommendations for
      dosage adjustments made twice weekly according to a simple dosing algorithm based on mean
      fasting glucose values during the previous 3-4 days.

      Subjects will receive standard diabetes education refresher training at the beginning of the
      trial, including review of insulin dose administration and titration, carbohydrate counting
      (or other dietary planning as deemed appropriate by the investigator), avoidance of
      hypoglycemia, and management of exercise and stress.

      Post meal (60-90 min after start of meal) goals will be <140 mg/dL. A test meal study
      (standardized liquid test meal) to be conducted at the beginning of treatment (baseline
      study) and at the end of the six week treatment period (treatment comparison study). Subjects
      will also perform blinded continuous glucose monitoring during 4 weeks of study (i.e weeks
      1,3,5 and 7 of study)

      Throughout study, subjects will be asked to perform frequent self-monitoring of blood glucose
      (SMBG), at least 6 times per day (before and 60-90 minutes after each meal) during 3 or more
      days of each week. This will serve as data for therapeutic decision-making as well as for
      data collection.
    

Intervention name(s): HDV insulin lispro 100 UNT/ML; Insulin Lispro 100 UNT/ML
Intervention type(s): Drug; Drug
Intervention description(s): HDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.; Sterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro
Other intervention name(s): Hepatic Directed Vesicle insulin lispro 100 UNT/ML; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, active comparator controlled (insulin lispro) to HDV insulin lispro, multiple dose safety, tolerability and efficacy study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment