Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control

NCT03096392 | Completed Phase 2 FDA Drug

• 1 other identifier: DP 01-2017-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• The amount of time, in minutes, glucose levels are within range (70-180 mg/dL)

  evaluate continuous glucose monitoring (CGM) profiles during treatment with HDV insulin lispro versus insulin lispro alone, with specific focus on time in range (70-180 mg/dL)

  6 weeks

Secondary Outcomes (6)

• The number of events that blood glucose is equal to or less than 70 mg/dL

  6 weeks

• The number of events blood glucose is less than 54 mg/dL

  6 weeks

• Postprandial glucose levels in mg/dL following test meal challenge

  6 weeks

• HbA1c levels in percentage (%) at beginning of trial compared to HbA1c levels at the end of the study

  6 weeks

• Self-Monitoring Blood Glucose (SMBG) results in mg/dL before and after every meal

  6 weeks

Study Arms (2)

HDV insulin lispro 100 UNT/mL

EXPERIMENTAL

insulin lispro with 0.8 ml HDV added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment)

Drug: HDV insulin lispro 100 UNT/ML

insulin lispro 100 UNT/ML

ACTIVE COMPARATOR

insulin lispro with 0.8 ml sterile water for injection added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment)

Drug: Insulin Lispro 100 UNT/ML

Interventions

HDV insulin lispro 100 UNT/ML DRUG

HDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.

Also known as: Hepatic Directed Vesicle insulin lispro 100 UNT/ML

HDV insulin lispro 100 UNT/mL

Insulin Lispro 100 UNT/ML DRUG

Sterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro

Also known as: Humalog

insulin lispro 100 UNT/ML

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study
• T1DM ≥12 months
• C-peptide \<0.6 ng/mL (single retest allowed)
• Treatment with rapid analog insulin for the previous 6 months and willing to use insulin vial and syringe to deliver rapid acting insulin during the study
• Currently using either insulin glargine (U100 only) or insulin degludec for basal insulin therapy for at least 4 weeks prior to study
• Not using insulin pump delivery systems during the previous 3 months
• Familiarity with continuous glucose monitoring (CGM) technology; subjects need to be not currently using CGM; subjects will NOT use unblinded CGM during the treatment period of the trial
• Willingness to use insulin lispro as the analog bolus insulin during the study period
• BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
• %≤A1C≤7.9% (single retest allowed)

You may not qualify if:

• Known or suspected allergy to any component of any of the study drugs in this trial.
• A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
• As judged by the investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position).
• History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the patient.
• As judged by the Investigator, clinically significant findings in routine laboratory data
• Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
• Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.) during the 4 weeks prior to randomization
• Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
• Use of e-cigarettes or other nicotine-containing products for the previous 3 months
• Current addiction to alcohol or substances of abuse as determined by the Investigator.
• Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device \[IUD\], oral or injectable contraceptives, barrier methods or abstinence as per investigator discretion).
• Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
• Symptomatic gastroparesis.
• Receipt of any investigational drug within 4 weeks of Visit 2 in this study
• Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data

Sponsors & Collaborators

• Diasome Pharmaceuticals: lead
• Integrium: collaborator

Study Sites (5)

Barbara Davis Center for Diabetes, University of Colorado

Aurora, Colorado, 80045, United States

Location

Baptist Diabetes Associates

Miami, Florida, 33156, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78749, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Douglas B Muchmore, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects, investigators, monitors, sponsor and sponsor representatives are blinded to the treatment group and treatment to patients are randomized. The group randomizing the subjects, the pharmacist preparing the drug, the party shipping the drug are unblinded but do not have contact with the blinded parties. An unblinded monitor will monitor any activities performed by unblinded parties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind, active comparator controlled (insulin lispro) to HDV insulin lispro, multiple dose safety, tolerability and efficacy study

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 30, 2017
• Study Start: April 18, 2017
• Primary Completion: November 15, 2017
• Study Completion: March 18, 2018
• Last Updated: July 31, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)