What is the mechanism of action of this treatment?

The most common treatments for type 2 diabetes include GLP-1 receptor agonists and dual GIP and GLP-1 receptor agonists like Tirzepatide. GLP-1 receptor agonists work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which helps to lower blood glucose levels and promote weight loss. Tirzepatide, a dual GIP and GLP-1 receptor agonist, combines these effects with additional benefits from GIP receptor activation, potentially offering superior glycemic control and weight loss. These mechanisms are crucial for diabetes patients as they address multiple aspects of the disease, improving overall metabolic health and reducing the risk of complications.

What side effects are associated with this type of intervention?

Common treatments for diabetes, particularly GLP-1 receptor agonists like dulaglutide, liraglutide, and exenatide, often have gastrointestinal side effects such as nausea, vomiting, and diarrhea. These symptoms are typically more pronounced during the initial months of therapy. Hypoglycemia is a less common but notable side effect, especially when these drugs are combined with other glucose-lowering medications like sulfonylureas. SGLT2 inhibitors, another class of diabetes medications, can cause urinary tract infections and genital infections, and have been associated with an increased risk of amputations in some studies. Overall, while these treatments are effective in managing blood glucose levels, they require careful monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes. Liraglutide was approved based on its efficacy in improving glycemic control and its additional benefits on weight loss and cardiovascular outcomes. Extended-release exenatide was approved for its significant improvement in glycemic control in pediatric patients. Dulaglutide received approval for its efficacy in both adults and adolescents, showing significant reductions in A1C levels. These drugs, similar to Tirzepatide, work by enhancing insulin secretion and inhibiting glucagon release, thereby improving blood sugar levels.

What other types of research exist?

Promising alternatives to Tirzepatide for diabetes treatment in 2024 include: 1) SAR425899, a dual GLP-1/glucagon receptor agonist, which has shown improved postprandial glucose metabolism compared to liraglutide. 2) Dulaglutide, a GLP-1 receptor agonist, which has demonstrated efficacy in glycemic control and cardiovascular outcomes. 3) Exenatide extended-release, another GLP-1 receptor agonist, approved for pediatric use and effective in improving glycemic control. These alternatives offer different mechanisms and benefits that may be suitable for various patient needs.

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Tirzepatide for Pediatric Type 2 Diabetes (SURPASS-PEDS Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.

Male or female, aged 10 to below 18 years at screening visit

Must not have

After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome

Had chronic or acute pancreatitis any time prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing tirzepatide, a medication that helps control blood sugar levels, in children and teenagers with type 2 diabetes. These participants are already taking other diabetes medications like metformin or basal insulin. Tirzepatide works by helping the body use insulin more effectively and reducing sugar production in the liver. Tirzepatide is a new medication being tested for its effectiveness and safety in people with type 2 diabetes.

Who is the study for?

This trial is for children and teenagers aged 10 to under 18 with type 2 diabetes, who are already taking metformin or basal insulin. They should have a stable dose for at least 90 days prior to screening, an HbA1c level over 6.5% but not above 11%, weigh at least 50 kg (110 pounds), and have a BMI above the 85th percentile for their age and gender.

What is being tested?

The study tests the safety and effectiveness of Tirzepatide in two different doses compared to a placebo in young patients with type 2 diabetes inadequately controlled by metformin or basal insulin. It involves around sixty weeks of participation, including up to fourteen clinic visits and six phone calls.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with diabetes medications like Tirzepatide may include low blood sugar levels, nausea, diarrhea, abdominal pain, increased heart rate, headache, fatigue among others.

Eligibility Criteria

Inclusion Criteria

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

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I weigh at least 110 pounds and my BMI is in the top 15% for my age and gender.

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I am between 10 and 17 years old.

Exclusion Criteria

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

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I have had diabetic ketoacidosis or hyperosmolar syndrome after being diagnosed with type 2 diabetes.

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I have had pancreatitis before.

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I am not pregnant, breastfeeding, or planning to become pregnant.

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I have Type 1 diabetes or positive for specific diabetes antibodies.

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I've had a severe low blood sugar episode or didn't notice my low blood sugar at least once in the last 6 months.

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I or my family have a history of MTC or MEN2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change From Baseline PedsQL (3.2) Diabetic Module

Change From Baseline in PedsQL Generic Core Scale

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tirzepatide Dose 2Experimental Treatment1 Intervention

Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Group II: Tirzepatide Dose 1Experimental Treatment1 Intervention

Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Group III: PlaceboPlacebo Group2 Interventions

Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.

0 / 8Eligibility 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

The most common treatments for type 2 diabetes include GLP-1 receptor agonists and dual GIP and GLP-1 receptor agonists like Tirzepatide. GLP-1 receptor agonists work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which helps to lower blood glucose levels and promote weight loss. Tirzepatide, a dual GIP and GLP-1 receptor agonist, combines these effects with additional benefits from GIP receptor activation, potentially offering superior glycemic control and weight loss. These mechanisms are crucial for diabetes patients as they address multiple aspects of the disease, improving overall metabolic health and reducing the risk of complications.

Cardiovascular effects of GLP-1 receptor agonism.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.[Significance of combination therapy with an insulin sensitizer and a DPP-4(dipeptidyl peptidase-4) inhibitor].