Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03938740|
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : April 2, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: HDV-Insulin Lispro and Insulin Degludec (-40%) Drug: HDV-Insulin Lispro and Insulin Degludec (-10%)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 18, 2019|
|Actual Primary Completion Date :||December 6, 2019|
|Actual Study Completion Date :||March 18, 2020|
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%)
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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%.
- 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938740
|United States, California|
|Mills-Peninsula Medical Center, Diabetes Research Institute|
|San Mateo, California, United States, 94401|
|United States, Colorado|
|Barbara Davis Center for Diabetes|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|
|Endocrine Research Solutions, Inc.|
|Roswell, Georgia, United States, 30076|
|United States, North Carolina|
|Diabetes & Endocrinology Consultants, PC|
|Morehead City, North Carolina, United States, 28557|
|United States, Texas|
|Texas Diabetes & Endocrinology, PA|
|Austin, Texas, United States, 78749|
|Texas Diabetes & Endocrinology, PA|
|Round Rock, Texas, United States, 78681|
|Study Director:||Marc Penn, MD, PhD||Diasome Pharmaceuticals|
|Responsible Party:||Diasome Pharmaceuticals|
|Other Study ID Numbers:||
|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|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Insulin, Globin Zinc
Physiological Effects of Drugs