The safety and efficacy of tirzepatide in children or teenagers with type 2 diabetes

Phase 3

Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Registration Number: CTRI/2022/07/044269

Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

2. 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.

3. Have HbA1c >6.5% to =11% at screening

4. 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

1. Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies.

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

3. Have had =1 episode of severe hypoglycemia and/or =1 episode of hypoglycemic unawareness within the last 6 months.

4. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).

5. Had chronic or acute pancreatitis any time prior to study entry.

6. Female participants who are pregnant or breast feeding or intending to become pregnant.

7. Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c).Timepoint: Baseline, Week 30

Secondary Outcome Measures

Name	Time	Method
1. Change from Baseline in HbA1c (Individual Doses). <br/ ><br>2. Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched). <br/ ><br>3. Change From Baseline in Fasting Serum Glucose (FSG). <br/ ><br>4. Change From Baseline for Serum Lipid Levels. <br/ ><br>5. Change From Baseline in Height Standard Deviation Score (SDS). <br/ ><br>6. Change From Baseline in Weight SDS.Timepoint: Baseline, Week 30;1. Change From Baseline in PedsQL Generic Core Scale. <br/ ><br>2. Change From Baseline PedsQL (3.2) Diabetic ModuleTimepoint: Baseline, Week 52;1. Percentage of Participants Who Achieve =6.5% of HbA1c. <br/ ><br>2. Percentage of Participants Who Achieve less than 7.0% of HbA1c. <br/ ><br>3. Percentage of Participants Who Achieve less than 5.7% of HbA1c.Timepoint: Week 30;Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of TirzepatideTimepoint: Baseline to Week 30