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Insulin

HDV-Insulin Lispro for Type 1 Diabetes (OPTI-2 Trial)

Phase 2
Recruiting
Led By Ruth Weinstock, MD
Research Sponsored by Diasome Pharmaceuticlas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Screening A1C >= 6.5% and <= 9.0% daily insulin dose <= 1.25 U/kg/day
Clinical diagnosis of Type 1 diabetes with C-peptide <0.6 nmol/L and using insulin for at least 6 months
Must not have
Current use of hydroxyurea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 7 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test if delivering insulin directly to the liver can help improve low blood sugar in Type 1 diabetes patients. Participants will monitor their blood sugar levels using continuous glucose monitoring and work with their

Who is the study for?
This trial is for adults with Type 1 Diabetes who are already using Insulin Degludec. Participants should be willing to monitor their blood sugar continuously and work with doctors on dosing. Specific inclusion and exclusion criteria details were not provided.
What is being tested?
The study compares HDV-Insulin Lispro, which targets the liver, against regular Insulin Lispro in managing blood sugar levels in Type 1 diabetes patients over a period of up to 32 weeks.
What are the potential side effects?
Potential side effects may include typical insulin-related reactions such as low blood sugar episodes, injection site reactions, weight gain, allergic reactions, and possibly liver-specific effects due to targeted action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My A1C is between 6.5% and 9.0%, and I use 1.25 units or less of insulin per kilogram of my body weight daily.
Select...
I have Type 1 diabetes, use insulin, and my C-peptide level is below 0.6 nmol/L.
Select...
I am willing to use only the study's insulin for my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking hydroxyurea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
hypoglycemia events
hypoglycemia percentage of time
Secondary study objectives
blood chemistry values

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HDV Lispro (HDV-L)Experimental Treatment1 Intervention
Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin
Group II: Lispro (LIS)Active Control1 Intervention
Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin

Find a Location

Who is running the clinical trial?

Diasome Pharmaceuticlas, Inc.Lead Sponsor
Ruth Weinstock, MDPrincipal InvestigatorState University of New York - Upstate Medical University
1 Previous Clinical Trials
200 Total Patients Enrolled
Bruce W Bode, MDPrincipal InvestigatorAtlanta Diabetes Associates
2 Previous Clinical Trials
231 Total Patients Enrolled
~86 spots leftby Jun 2025
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