21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus

NCT03156361 | Completed Phase 2 FDA Drug

• 1 other identifier: DP 01-2017-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glucose area under the curve

  To evaluate glucose response (incremental AUC) to standardized test meal challenge following 21 days of CSII treatment with HDV insulin lispro versus insulin lispro diluted with sterile water

  21 days

Secondary Outcomes (1)

• total units Insulin

  21 days

Study Arms (2)

HDV insulin lispro 100 UNIT/mL

EXPERIMENTAL

Hepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.

Drug: HDV insulin lispro 100 UNIT/mL

Insulin Lispro 100 UNIT/mL

ACTIVE COMPARATOR

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

Drug: Insulin Lispro 100 Units/mL

Interventions

HDV insulin lispro 100 UNIT/mL DRUG

Hepatic Directed Vesicle (HDV) added to commercial insulin lispro

Also known as: HDV Humalog

HDV insulin lispro 100 UNIT/mL

Insulin Lispro 100 Units/mL DRUG

Sterile Water for Injection added to commercial insulin lispro

Also known as: Humalog

Insulin Lispro 100 UNIT/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:

• T1DM ≥12 months
• C-peptide \<0.6 ng/mL (a single re-test is allowable)
• Treatment with rapid analog insulin by CSII for the previous 6 months
• Familiarity with continuous glucose monitoring (CGM) technology; subjects nee d not be currently using CGM but should have used it in the past. Personal (unblinded) CGM will NOT be allowed during the study
• Willingness to use insulin lispro as the analog insulin during the study period
• Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study
• BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
• A1C≤9.0% (a single re-test is allowable)

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.
• Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)
• Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
• 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.

Sponsors & Collaborators

• Diasome Pharmaceuticals: lead
• Integrium: collaborator

Study Sites (1)

Atlanta Diabetes Association

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Interventions

Insulin Lispro

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 Muchmore, MD

  Diasome Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 18, 2017
• Primary Completion: January 15, 2018
• Study Completion: March 15, 2018
• Last Updated: July 31, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)