What side effects are associated with this type of intervention?

Common treatments for Diabetes Mellitus, particularly those similar to ZT-01 that increase glucagon levels, include GLP-1 receptor agonists and other incretin-based therapies. The most frequent side effects are gastrointestinal symptoms such as nausea, vomiting, and diarrhea, which typically lessen over time. There is also a risk of pancreatitis and, rarely, pancreatic cancer. Hypoglycemia is less common compared to insulin therapy. Other potential side effects include injection site reactions and an increased heart rate.

What prior FDA approvals exist?

ZT-01, which increases glucagon levels to prevent hypoglycemia, is similar in its approach to glucagon-like peptide-1 (GLP-1) receptor agonists. FDA-approved GLP-1 receptor agonists include drugs like liraglutide and dulaglutide, which are used to improve glycemic control in patients with type 2 diabetes. These drugs work by enhancing insulin secretion and inhibiting glucagon release, thereby lowering blood glucose levels. Additionally, treatments like exenatide and semaglutide have also been approved for their efficacy in managing diabetes and preventing hypoglycemia. These therapies represent a significant advancement in diabetes management, offering options that help maintain stable blood glucose levels and reduce the risk of hypoglycemia.

What other types of research exist?

Promising alternatives to ZT-01 for Diabetes Mellitus patients include GLP-1 receptor agonists such as liraglutide, semaglutide, dulaglutide, and polyethylene glycol loxenatide. These medications have shown efficacy in improving glycemic control and have a favorable safety profile in clinical trials.

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Hormone Therapy

ZT-01 for Type 1 Diabetes (ZONE Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Diabetes Mellitus include insulin therapy, GLP-1 receptor agonists, and medications like ZT-01 that increase glucagon levels. Insulin therapy involves administering insulin to help regulate blood sugar levels by facilitating glucose uptake into cells. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps control blood sugar levels. ZT-01, specifically, increases glucagon levels during hypoglycemia, preventing dangerously low blood sugar levels. Understanding these mechanisms is crucial for patients as it helps them manage their condition effectively and avoid complications such as hypoglycemia and hyperglycemia.

Phase 2

Recruiting

Research Sponsored by Zucara Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has type 1 diabetes for at least 5 years

Be older than 18 years old

Must not have

Clinically significant kidney disease

Has been hospitalized for diabetic ketoacidosis (DKA) more than once within previous 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during each 28 day treatment period and 2-week followup

Summary

This trial is testing a drug called ZT-01 to help adults with type 1 diabetes who have low blood sugar at night. ZT-01 increases a hormone that raises blood sugar levels. The study will see if ZT-01 reduces nighttime low blood sugar episodes and check its safety.

Who is the study for?

Adults with type 1 diabetes who have had the condition for at least 5 years and experience low blood sugar at night. They must have an HbA1c level of 10% or less, a BMI between 18.5 to <33 kg/m^2, and no severe hypoglycemia or hospitalizations for diabetic ketoacidosis recently. People with abnormal liver function, significant kidney disease, other specific health conditions, or using automated insulin delivery systems cannot participate.

What is being tested?

The trial is testing ZT-01's ability to prevent nighttime low blood sugar in people with type 1 diabetes by increasing glucagon levels. Participants will self-inject either ZT-01 at varying doses or a placebo before bed while wearing a glucose monitor over two separate periods without knowing which they're receiving.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to hormone changes due to increased glucagon levels from ZT-01 injections. Blood pressure, temperature checks, ECG readings and lab tests (blood/urine) will help monitor safety throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had type 1 diabetes for 5 years or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious kidney condition.

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I have been hospitalized for diabetic ketoacidosis more than once in the last 6 months.

Select...

I've had at least one severe low blood sugar incident needing help in the last month.

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My liver isn't working properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during each 28 day treatment period and 2-week followup

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during each 28 day treatment period and 2-week followup

This trial's timeline: 3 weeks for screening, Varies for treatment, and during each 28 day treatment period and 2-week followup for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of nocturnal hypoglycemia

Secondary study objectives

Glucose time below range

Incidence and severity of adverse events (AEs)

Incidence of hypoglycemia

Other study objectives

Glucose time in range

Mean glucose concentration

Mean glycemic variability

Trial Design

3Treatment groups

Experimental Treatment

Group I: ZT-01 7 mgExperimental Treatment2 Interventions

Participants receive placebo and ZT-01 7 mg each by subcutaneous injection daily for 28 days, randomized to order

Group II: ZT-01 22 mgExperimental Treatment2 Interventions

Participants receive placebo and ZT-01 22 mg by subcutaneous injection daily for 28 days, randomized to order

Group III: ZT-01 15 mgExperimental Treatment2 Interventions

Participants receive placebo and ZT-01 15 mg by subcutaneous injection daily for 28 days, randomized to order

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetes Mellitus include insulin therapy, GLP-1 receptor agonists, and medications like ZT-01 that increase glucagon levels. Insulin therapy involves administering insulin to help regulate blood sugar levels by facilitating glucose uptake into cells. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps control blood sugar levels. ZT-01, specifically, increases glucagon levels during hypoglycemia, preventing dangerously low blood sugar levels. Understanding these mechanisms is crucial for patients as it helps them manage their condition effectively and avoid complications such as hypoglycemia and hyperglycemia.

Update in Cardiovascular Safety of Glucagon Like Peptide-1 Receptor Agonists in Patients With Type 2 Diabetes. A Mixed Treatment Comparison Meta-Analysis of Randomised Controlled Trials.A patient-centered approach to managing patients with type 2 diabetes.