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A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05260021
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.

The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 T2D T2DM (Type 2 Diabetes Mellitus) Glucose Metabolism Disorders Endocrine System Diseases Metabolic Disease Drug: Tirzepatide Dose 1 Drug: Tirzepatide Dose 2 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : November 30, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide Dose 1

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

 Drug: Tirzepatide Dose 1
Administered SC
Experimental: Tirzepatide Dose 2

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

 Drug: Tirzepatide Dose 2
Administered SC
Placebo Comparator: Placebo

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.

 Drug: Tirzepatide Dose 1
Administered SC

Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 30 ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 30 ]
  2. Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched) [ Time Frame: Baseline, Week 30 ]
  3. Change From Baseline in Fasting Serum Glucose (FSG) [ Time Frame: Baseline, Week 30 ]
  4. Percentage of Participants Who Achieve ≤6.5% of HbA1c [ Time Frame: Week 30 ]
  5. Percentage of Participants Who Achieve <7.0% of HbA1c [ Time Frame: Week 30 ]
  6. Percentage of Participants Who Achieve <5.7% of HbA1c [ Time Frame: Week 30 ]
  7. Change From Baseline for Serum Lipid Levels [ Time Frame: Baseline, Week 30 ]
  8. Change From Baseline in Height Standard Deviation Score (SDS) [ Time Frame: Baseline, Week 30 ]
  9. Change From Baseline in Weight SDS [ Time Frame: Baseline, Week 30 ]
  10. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide [ Time Frame: Baseline to Week 30 ]
  11. Change From Baseline in PedsQL Generic Core Scale [ Time Frame: Baseline, Week 52 ]
    The PedsQL Generic Core Scale has 23 items that measure the core dimensions of health: physical, emotional, and social and school functioning. Scores range from 0 to 100. Higher scores indicate better health related quality of life.

  12. Change From Baseline PedsQL (3.2) Diabetic Module [ Time Frame: Baseline, Week 52 ]
    The PedsQL 3.2 Diabetes Module has 33 items for ages 13 to 45 years, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms, treatment barriers, treatment adherence, worry and communication. Scores range from 0 to 100. Higher scores indicate less problems.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 10 to below 18 years at screening visit
  • Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
  • Have HbA1c >6.5% to ≤11% at screening
  • 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.

Exclusion Criteria:

  • Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
  • After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
  • Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
  • Had chronic or acute pancreatitis any time prior to study entry
  • Female participants who are pregnant or breast feeding or intending to become pregnant.
  • Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260021


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05260021    
Other Study ID Numbers: 17121
I8F-MC-GPGV ( Other Identifier: Eli Lilly and Company )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
GLP-1 RA
Glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
Incretins
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Tirzepatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists