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Diabetes Mellitus, Type 1Phase 2NCT03938740

Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec

A Phase 2 study testing HDV-Insulin Lispro and Insulin Degludec (-40%) and HDV-Insulin Lispro and Insulin Degludec (-10%) in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multi-center, open-label, multiple dose safety, tolerability and efficacy study Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
HDV-Insulin Lispro and Insulin Degludec (-40%) and HDV-Insulin Lispro and Insulin Degludec (-10%)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
7 sitesUnited States
Study dates
18 Mar 2019to 18 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female of age 18 to 65 years, inclusive.
  • If female of child-bearing potential, must agree for the duration of the study. to use adequate contraceptive measures, such as, intra-uterine device [IUD], oral or injectable contraceptives, or barrier method plus spermicide.
  • Has at Screening been diagnosed as T1DM for at least 12 months.
  • Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed).
  • Has at Screening been on treatment with rapid analog insulin for the previous six (6) months.
  • Has at Screening willingness to use continuous glucose monitoring (CGM) technology throughout study.
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  • Is, for the duration of the study, willing to use insulin lispro as the only analog bolus insulin and insulin degludec as the only basal insulin.
  • Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2.
  • Has at Screening HbA1c ≥6.5% and ≤8.5%.

Who cannot join

  • Has known or suspected allergy to any component of any of the study drugs in this trial.
  • Is, at Screening, pregnant or breast-feeding, or intends to become pregnant at any time during the duration of the study.
  • Has, at Screening, as judged by the Site Investigator, a history or current evidence of any of the following complications of diabetes: proliferative retinopathy or maculopathy, severe neuropathy (in particular, autonomic neuropathy), symptomatic gastroparesis.
  • Is, at Screening, judged by the Site Investigator to have a current addiction to alcohol or substances of abuse.
  • Is, at Screening, using one or more 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 (e.g., beta blockers, systemic corticosteroids at pharmacologic doses, cancer chemotherapies.).
  • Has at Screening any of the following findings, unless approved by both the Site Investigator and the Medical Monitor:
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  • Uncontrolled hypertension, defined as diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the sitting position;
  • History of or findings on EKG of cardiac arrhythmia or conduction defect;
  • Clinically significant abnormalities on Screening laboratory studies
  • Has, within one (1) month prior to Screening, used either oral anti-diabetic medication or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.).
  • Has, within one (1) month prior to Screening, received any investigational drug.
  • Has, within two (2) months prior to Screening, used an insulin pump delivery system.
  • Has, within three (3) months prior to Screening, smoked tobacco or used any smokeless tobacco or nicotine delivery system (inhaled, oral or buccal).
  • Has at Screening, as judged by the Site Investigator, any condition (intrinsic or extrinsic) that could reasonably be expected to interfere with trial participation, confound evaluation of the data, or pose additional risk to adhering to the study protocol. Examples of such conditions include but are not limited to:
  • Clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems;
  • History of such an illness or disease
  • Diminished mental capacity, psychological or behavioral dysfunction, unwilling or resistant to protocol requirements, language barriers

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, PA

    Austin, Texas, 78749

  • Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes & Endocrinology, PA

    Round Rock, Texas, 78681

  • Mills-Peninsula Medical Center, Diabetes Research Institute

    San Mateo, California, 94401

Other trials in United States

About this study

Official title: An Exploratory Randomized Open-Label 2-Arm Comparison of Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec to Determine Optimum Basal Insulin Dosing Regimens in Type 1 Diabetes Mellitus Subjects

Multi-center, open-label, multiple dose safety, tolerability and efficacy study

Read the detailed description

This is a 24-week, open-label, multiple dose safety, tolerability and efficacy study. There is a 12-week run-in phase when all subjects receive Insulin Lispro and Insulin Degludec for 12 weeks. After completing the run-in period, subjects then are randomized to a treatment group of either HDV- Insulin lispro + Insulin Degludec (Degludec dose reduced by 40%) or HDV-Insulin lispro+ Insulin Degludec (Degludec dose reduced by 10%) for 12 weeks of treatment.

Being tested
HDV-Insulin Lispro and Insulin Degludec (-40%), HDV-Insulin Lispro and Insulin Degludec (-10%)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDV-Insulin Lispro and Insulin Degludec (-40%)Drug

    HDV-Insulin Lispro and Insulin Degludec (-40%)

  • HDV-Insulin Lispro and Insulin Degludec (-10%)Drug

    HDV-Insulin Lispro and Insulin Degludec (-10%)

Study groups in NCT03938740
Study groupRoleWhat they receive
HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%ExperimentalHDV-Insulin Lispro and Insulin Degludec dose reduced by 40%
Receives: Drug: HDV-Insulin Lispro and Insulin Degludec (-40%)
HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%ExperimentalHDV-Insulin Lispro and Insulin Degludec dose reduced by 10%
Receives: Drug: HDV-Insulin Lispro and Insulin Degludec (-10%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period

    Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period

    Measured: 24 weeks

  2. Basal/bolus ratios during the last 2 weeks of the treatment period

    Basal/bolus ratios during the last 2 weeks of the treatment period

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start18 Mar 2019
  3. Primary completion6 Dec 2019
  4. Study completion18 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03938740
Sponsor's protocol ID
DP 01-2019-01
Status last verified
Mar 2020
First submitted
15 Apr 2019
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HDV-Insulin Lispro and Insulin Degludec (-40%) and HDV-Insulin Lispro and Insulin Degludec (-10%) in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03938740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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