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

Primary Purpose

Type1 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HDV insulin lispro 100 UNIT/mL

Insulin Lispro 100 Units/mL

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Atlanta Diabetes Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HDV insulin lispro 100 UNIT/mL

Insulin Lispro 100 UNIT/mL

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total units Insulin

To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment

Full Information

NCT ID

NCT03156361

First Posted

May 15, 2017

Last Updated

July 29, 2018

Sponsor

Diasome Pharmaceuticals

Collaborators

Integrium

1. Study Identification

Unique Protocol Identification Number

NCT03156361

Brief Title

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

Official Title

A Randomized Controlled Trial Comparing 21 Days of Continuous Subcutaneous Insulin Infusion (CSII) Using Hepatic Directed Vesicle (HDV) Insulin to Standard CSII in Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

May 18, 2017 (Actual)

Primary Completion Date

January 15, 2018 (Actual)

Study Completion Date

March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diasome Pharmaceuticals

Collaborators

Integrium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study. The study will consist of three periods. Total duration will be approximately nine weeks, including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment periods. Subjects will be screened and then they will undergo a week of baseline CGM. They will then be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro followed by three weeks of treatment with insulin lispro diluted with sterile water to match the insulin concentration in HDV-lispro, or the same treatments in the reverse order. A test meal study (standardized liquid test meal) is to be conducted at the beginning of treatment (baseline study) and at the end of each three week treatment period. As noted above, frequent blood samples will be collected for glucose and insulin levels during the first (baseline study) test meal; during the two test meals performed after the two treatment periods the same sampling for glucose and insulin will be performed, with the addition of collecting samples for glucagon levels. Subjects will also perform blinded continuous glucose monitoring throughout the entirety of the study (7 weeks). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HDV insulin lispro 100 UNIT/mL

Arm Type

Experimental

Arm Description

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

Arm Title

Insulin Lispro 100 UNIT/mL

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HDV insulin lispro 100 UNIT/mL

Other Intervention Name(s)

HDV Humalog

Intervention Description

Hepatic Directed Vesicle (HDV) added to commercial insulin lispro

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro 100 Units/mL

Other Intervention Name(s)

Humalog

Intervention Description

Sterile Water for Injection added to commercial insulin lispro

Primary Outcome Measure Information:

Title

Glucose area under the curve

Description

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

Time Frame

21 days

Secondary Outcome Measure Information:

Title

total units Insulin

Description

To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas Muchmore, MD

Organizational Affiliation

Diasome Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Atlanta Diabetes Association

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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