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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03938740

Recruitment Status Completed

First Posted May 6, 2019

Last update posted April 2, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Diabetes Mellitus, Type 1
  • Intervention/Treatment: Drug: HDV-Insulin Lispro and Insulin Degludec (-40%)
    Drug: HDV-Insulin Lispro and Insulin Degludec (-10%)
  • Phase: Phase 2
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 61 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
Experimental: HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%
HDV-Insulin Lispro and Insulin Degludec dose reduced by 40%
Drug: HDV-Insulin Lispro and Insulin Degludec (-40%)
HDV-Insulin Lispro and Insulin Degludec (-40%)
Experimental: HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%
HDV-Insulin Lispro and Insulin Degludec dose reduced by 10%
Drug: HDV-Insulin Lispro and Insulin Degludec (-10%)
HDV-Insulin Lispro and Insulin Degludec (-10%)
Outcome Measures
  • Primary Outcome Measures: 1. Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period [ Time Frame: 24 weeks ]
    Basal, bolus and total insulin doses (UOM=units) during the last 2 weeks of the treatment period
  • 2. Basal/bolus ratios during the last 2 weeks of the treatment period [ Time Frame: 24 weeks ]
    Basal/bolus ratios during the last 2 weeks of the treatment period
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Male or female of age 18 to 65 years, inclusive.

2. 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.

3. Has at Screening been diagnosed as T1DM for at least 12 months.

4. Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed).

5. Has at Screening been on treatment with rapid analog insulin for the previous six (6)
months.

6. Has at Screening willingness to use continuous glucose monitoring (CGM) technology
throughout study.

7. 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.

8. Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2.

9. Has at Screening HbA1c ≥6.5% and ≤8.5%.

Exclusion Criteria:

1. Has known or suspected allergy to any component of any of the study drugs in this
trial.

2. Is, at Screening, pregnant or breast-feeding, or intends to become pregnant at any
time during the duration of the study.

3. 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.

4. Is, at Screening, judged by the Site Investigator to have a current addiction to
alcohol or substances of abuse.

5. 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.).

6. Has at Screening any of the following findings, unless approved by both the Site
Investigator and the Medical Monitor:

- 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

7. 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.).

8. Has, within one (1) month prior to Screening, received any investigational drug.

9. Has, within two (2) months prior to Screening, used an insulin pump delivery system.

10. Has, within three (3) months prior to Screening, smoked tobacco or used any smokeless
tobacco or nicotine delivery system (inhaled, oral or buccal).

11. 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

Contacts and Locations
Contacts
Locations

United States, California
Mills-Peninsula Medical Center, Diabetes Research Institute
San Mateo

United States, Colorado
Barbara Davis Center for Diabetes
Aurora

United States, Georgia
Atlanta Diabetes Associates
Atlanta

United States, Georgia
Endocrine Research Solutions, Inc.
Roswell

United States, North Carolina
Diabetes & Endocrinology Consultants, PC
Morehead City

United States, Texas
Texas Diabetes & Endocrinology, PA
Austin

United States, Texas
Texas Diabetes & Endocrinology, PA
Round Rock

Sponsors and Collaborators

Diasome Pharmaceuticals

Investigators

Study Director: Marc Penn, MD, PhD Diasome Pharmaceuticals

More Information
  • Responsible Party: Diasome Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03938740 History of Changes
  • Other Study ID Numbers: DP 01-2019-01
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: April 2, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 1