Diabetes Mellitus, Type 1Phase 2OPTI-2NCT06238778
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
A Phase 2 study testing HDV-Lispro and Lispro in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 27 sites in United States.
Trial summary
The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- HDV-Lispro and Lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 27 sitesUnited States
- Study dates
- 28 Dec 2023to 16 Dec 2025
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis Type 1 diabetes with C-peptide <=0.6 ng/mL and using insulin for at least 6 months
- willing to use study provided insulin as the only bolus insulin and insulin degludec as the basal insulin
- willing to use CGM device throughout the study
- screening A1C >= 6.5% and <= 10.0% daily insulin dose <= 1.25 U/kg/day
Who cannot join
- known or specific allergy to any component of the study drug, the active comparator
- pregnant or breast-feeding, or plans to become pregnant at any time during duration of study
- current use of hydroxyurea
- use of noninsulin glucose-lowering medications other than metformin, weight loss medications or dietary supplements for weight loss within 30 days, or anticipated use during the course of the study
- received any investigational drug within prior 30 days
- Clinically significant abnormalities on screening laboratory testing including liver enzymes
- Presence of a medical condition or use of a medication that could compromise the results of the study or the safety of the subject (eg. alcohol or drug abuse, uncontrolled hypertension, history of transient ischemic attack or stroke within the last 12 months)
- employed by or having immediate family members employed by the sponsor or directly involved in conducting the clinical trial.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Asheville Clinical Research
Asheville, North Carolina, 28803
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes & Endocrinology
Austin, Texas, 78749
East Coast Institute for Research
Canton, Georgia, 30114
UNC EnDO Clinical Research Unit
Chapel Hill, North Carolina, 27514
Virginia Endocrinology Research
Chesapeake, Virginia, 23321
University of Chicago Kovler Diabetes Center
Chicago, Illinois, 60637
University Hospitals Medical Center
Cleveland, Ohio, 44106
University of Colorado, Barbara Davis Center
Denver, Colorado, 80045
Physician's East
Greenville, North Carolina, 27834
Marvel Clinical Research
Huntington Beach, California, 92647
Tekton Research, LLC
Irving, Texas, 75039
East Coast Institute for Research
Jacksonville, Florida, 32216
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046
Tekton Research, LLC
McKinney, Texas, 75069
Indiana Medical Research Institute
Merrillville, Indiana, 46410
University of Miami Diabetes Research Institute
Miami, Florida, 33136
Pasadena Clinical Trials
Pasadena, California, 91101
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Texas Diabetes % Endocrinology
Round Rock, Texas, 78681
Wasatch Clinical Research, LLC 310
Salt Lake City, Utah, 84107
Clinical Trials of Texas
San Antonio, Texas, 78229
Tekton Research, LLC
San Antonio, Texas, 78251
Endeavor Health
Skokie, Illinois, 60077
SUNY Upstate Medical University
Syracuse, New York, 13210
Diabetes Research Center
Tustin, California, 92780
Metabolic Research Institute
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec
The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.
Read the detailed description
Individuals age 18 up to 80 years with Type 1 diabetes using multiple daily injections of bolus insulin plus basal insulin will be enrolled into a double-blind randomized controlled trial to assess the efficacy, safety, and tolerability of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) versus lispro alone (LIS) used in combination with insulin degludec. The study includes (1), a screening period up to 3 weeks, (2), a Run-in Period of 2 weeks to assess eligibility and to transition to use of insulin lispro and insulin degludec and unmasked continuous glucose monitoring (CGM), )3), a 12-week dose optimization period to optimize bolus and basal insulin doses,, (4), a 13-week maintenance period, and (5), a 2 -week transition follow-up period.
The primary objective of the study is to determine if the addition of HDV to insulin lispro results in an improvement in glycemic control as defined by decreasing evidence of nocturnal hypoglycemia while maintaining or improving glycated hemoglobin (HbA1c). Other outcomes related to glycemic control will also be evaluated.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- HDV-Lispro, Lispro
- Keywords
- Diabetes Mellitus Type 1, CGM, Randomized, HDV, Lispro
- 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-LisproDrug
Also called HDV-L
HDV-L will be used as the mealtime insulin
LisproDrug
Also called LIS
Lispro will be used as the mealtime insulin
| Study group | Role | What they receive |
|---|---|---|
| HDV Lispro (HDV-L) | Experimental | Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin Receives: Drug: HDV-Lispro |
| Lispro (LIS) | Active comparator | Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin Receives: Drug: Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemia events
CGM-measured rates of nocturnal level 2 hypoglycemia events
Measured: during the first 6 weeks of the maintenance period
hypoglycemia percentage of time
CGM-measured nocturnal percent time
Measured: during the first 6 weeks of maintenance period
Secondary outcomes (1)
blood chemistry values
Triglyceride levels, Liver enzymes
Measured: baseline through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start28 Dec 2023
- Primary completion27 Oct 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized, double blind interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasome Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth Weinstock, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238778
- Sponsor's protocol ID
- DP 01-2023-01
- Acronym
- OPTI-2
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec
- ClinicalTrials.gov ID
- NCT06238778
- Acronym / sponsor ID
- OPTI-2 / DP 01-2023-01
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus Type 1, CGM, Randomized, HDV, Lispro
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.
Detailed description
Individuals age 18 up to 80 years with Type 1 diabetes using multiple daily injections of bolus insulin plus basal insulin will be enrolled into a double-blind randomized controlled trial to assess the efficacy, safety, and tolerability of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) versus lispro alone (LIS) used in combination with insulin degludec. The study includes (1), a screening period up to 3 weeks, (2), a Run-in Period of 2 weeks to assess eligibility and to transition to use of insulin lispro and insulin degludec and unmasked continuous glucose monitoring (CGM), )3), a 12-week dose optimization period to optimize bolus and basal insulin doses,, (4), a 13-week maintenance period, and (5), a 2 -week transition follow-up period.
The primary objective of the study is to determine if the addition of HDV to insulin lispro results in an improvement in glycemic control as defined by decreasing evidence of nocturnal hypoglycemia while maintaining or improving glycated hemoglobin (HbA1c). Other outcomes related to glycemic control will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind interventional study
| Arm | Type | Receives |
|---|---|---|
| HDV Lispro (HDV-L) | Experimental | Drug: HDV-LisproSubjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin |
| Lispro (LIS) | Active comparator | Drug: LisproSubjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis Type 1 diabetes with C-peptide <=0.6 ng/mL and using insulin for at least 6 months
- willing to use study provided insulin as the only bolus insulin and insulin degludec as the basal insulin
- willing to use CGM device throughout the study
- screening A1C >= 6.5% and <= 10.0% daily insulin dose <= 1.25 U/kg/day
Key exclusion criteria (8 listed)
- known or specific allergy to any component of the study drug, the active comparator
- pregnant or breast-feeding, or plans to become pregnant at any time during duration of study
- current use of hydroxyurea
- use of noninsulin glucose-lowering medications other than metformin, weight loss medications or dietary supplements for weight loss within 30 days, or anticipated use during the course of the study
- received any investigational drug within prior 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDV-LisproAlso: HDV-LHDV-L will be used as the mealtime insulin | Drug | HDV Lispro (HDV-L) |
| LisproAlso: LISLispro will be used as the mealtime insulin | Drug | Lispro (LIS) |
Primary outcome
hypoglycemia events
Time frame: during the first 6 weeks of the maintenance period
CGM-measured rates of nocturnal level 2 hypoglycemia events
hypoglycemia percentage of time
Time frame: during the first 6 weeks of maintenance period
CGM-measured nocturnal percent time
1 secondary outcome
blood chemistry values
Time frame: baseline through study completion, an average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Weinstock, MD principal investigator
State University of New York - Upstate Medical University
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDV-Lispro and Lispro in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 27 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 4 inclusion and 8 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
hypoglycemia events (time frame: during the first 6 weeks of the maintenance period). 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?
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 31 Jul 2026.