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Insulin

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

Q: Are individuals above the age of 40 eligible to participate in this recruitment phase for the clinical trial?

Individuals aged 18 to 79 are eligible for participation in this clinical trial.

Q: What are the potential risks associated with HDV Lispro (HDV-L) in individuals receiving medical treatment?

Based on our assessments at Power, the safety rating for HDV Lispro (HDV-L) is 2 out of a possible 3. This score reflects the Phase 2 nature of the trial where some evidence supports its safety but not yet efficacy.

Q: Which individuals would be considered ideal candidates for enrollment in this medical study?

Individuals aged between 18 and 79 years diagnosed with <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> are eligible for this research. The trial aims to recruit a total of 230 participants.

Q: Are patients currently being accepted to participate in this research study?

Affirmative. Information on clinicaltrials.gov highlights the ongoing search for suitable participants in this research study. This trial was first listed on January 23, 2024, and most recently revised on January 31, 2024. The investigation aims to recruit a total of 230 patients at one designated site.

Q: What is the upper limit for participant enrollment in this research investigation?

Indeed, the details on clinicaltrials.gov indicate that this current research study is actively seeking eligible participants. The trial was initially made available on January 23rd, 2024, and most recently revised on January 31st, 2024. There is a need to recruit around 230 patients from one designated site.

Phase 2

Recruiting

Led By Bruce W Bode, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, an average of 7 months

Awards & highlights

OPTI-2 Trial 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.Check my eligibility

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.See study design

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.

OPTI-2 Trial 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.

OPTI-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, an average of 7 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

hypoglycemia events

hypoglycemia percentage of time

Secondary outcome measures

blood chemistry values

Side effects data

From 2016 Phase 3 trial • 577 Patients • NCT01621178

37%

Blood creatinine increased

16%

Diarrhoea

14%

Nausea

11%

Glomerular filtration rate decreased

Vomiting

Influenza

Upper respiratory tract infection

Hypertension

Oedema peripheral

Dizziness

Constipation

Nasopharyngitis

Urinary tract infection

Weight increased

Hyperkalaemia

Back pain

Cough

Hypoglycaemia

Acute kidney injury

Acute myocardial infarction

Decreased appetite

Sinusitis

Pneumonia

Anaemia

Dehydration

Non-cardiac chest pain

Drug hypersensitivity

Pyrexia

Cholecystitis acute

Portal vein thrombosis

Postpericardiotomy syndrome

Renal injury

Clostridium difficile colitis

Gastroenteritis

Gastroenteritis viral

Groin abscess

Osteomyelitis

Pneumonia haemophilus

Tracheobronchitis

Toxicity to various agents

Rhabdomyolysis

Musculoskeletal chest pain

Cardiac failure

Cardiac failure acute

Cardiac failure congestive

Coronary artery disease

Ischaemic cardiomyopathy

Myocardial infarction

Abdominal abscess

Appendicitis

Gastric cancer

Carotid artery stenosis

Cerebrovascular accident

Cervical radiculopathy

Iiird nerve paralysis

Ischaemic stroke

Sciatica

Syncope

Aspiration

Hypertensive crisis

Visual acuity reduced

Peripheral vascular disorder

Acute coronary syndrome

Angina unstable

Abdominal pain lower

Gastritis

Gastrointestinal haemorrhage

Death

Haemoglobin decreased

Fluid retention

End stage renal disease

100%

80%

60%

40%

20%

Study treatment Arm

Dulaglutide 0.75 mg

Insulin Glargine

Dulaglutide 1.5 mg

OPTI-2 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Diasome Pharmaceuticlas, Inc.Lead Sponsor

Bruce W Bode, MDPrincipal InvestigatorAtlanta Diabetes Associates

2 Previous Clinical Trials

231 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 40 eligible to participate in this recruitment phase for the clinical trial?

"Individuals aged 18 to 79 are eligible for participation in this clinical trial."

Answered by AI

What are the potential risks associated with HDV Lispro (HDV-L) in individuals receiving medical treatment?

"Based on our assessments at Power, the safety rating for HDV Lispro (HDV-L) is 2 out of a possible 3. This score reflects the Phase 2 nature of the trial where some evidence supports its safety but not yet efficacy."

Answered by AI

Which individuals would be considered ideal candidates for enrollment in this medical study?

"Individuals aged between 18 and 79 years diagnosed with type 1 diabetes are eligible for this research. The trial aims to recruit a total of 230 participants."

Answered by AI

Are patients currently being accepted to participate in this research study?

"Affirmative. Information on clinicaltrials.gov highlights the ongoing search for suitable participants in this research study. This trial was first listed on January 23, 2024, and most recently revised on January 31, 2024. The investigation aims to recruit a total of 230 patients at one designated site."

Answered by AI

What is the upper limit for participant enrollment in this research investigation?

"Indeed, the details on clinicaltrials.gov indicate that this current research study is actively seeking eligible participants. The trial was initially made available on January 23rd, 2024, and most recently revised on January 31st, 2024. There is a need to recruit around 230 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec

2024. "Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06238778.

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