This is a study to help understand how dulaglutide compares to placebo (a shot that does not contain any active medicine) in children and teens (ages 10 to 17) with type 2 diabetes who may also be taking metformin and long-acting insulin (basal).

Phase 1

Conditions: Type 2 diabetes mellitus
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2016-000361-22-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Age 10 to less than 18 years old
2. Have type 2 diabetes mellitus, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening
7. Have a HbA1c of > 6.5 or = 11. If you are newly diagnosed, have a HbA1c in the range of > 6.5 or = 9.
8. Weight is at least 110 pounds or 50 kg

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known type 1 diabetes, or positive GAD 6 or IA2 antibodies, or history of diabetic ketoacidosis after taking diabetes medication.
2. A history or, or at risk for pancreatitis
3. Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid c-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result => 20 picograms per millilter (pg/ml) at screening.
4. A systolic blood pressure rate of => 160 millimeters of mercury (mmHg) or diastolic => 100 mmHg.
5. Active or treated cancer
6. A blood disorder where an accurate HbA1c may not be obtained.
7. A female of childbearing age, sexually active and not on birth control.
8. Pregnant or plan to be pregnant during the study, or breastfeeding.
9.Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit.
10. Have taken oral steroids within the last 60 days or more than 20 days use withing the past year or 1000 mcg of fluticasone propionate per day.
11. Using prescription weight loss medications in the last 30 days or plan to use them.
12. Taking psychiatric medications for depression or illness or attention deficit hyperactivity disroder (ADHD) if, the doses have changed within the last 3 months.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to test the hypothesis that dulaglutide (0.75 mg and 1.5 mg, pooled) given subcutaneously (SC) once a week for 26 weeks to children and adolescents with T2DM who have inadequate glycemic control, despite diet and exercise, with or without metformin and/or basal insulin is superior to placebo in the treatment of T2DM, as measured by baseline to Week 26 change in HbA1c. ;Secondary Objective: Change from baseline in fasting blood glucose at 26 weeks; Percentage of participants with HbA1c = or < than 6.5% at 26 weeks; Change from baseline in body mass index at 26 weeks; Change in HbA1c between baseline and 52 weeks; Percentage of patients with HbA1c = to or less than 6.5 at week 52; Change in BMI between baseline and 52 weeks;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Week 26

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): E.5.2 Secondary End Points <br>Change from baseline in HbA1c<br>Change from baseline in fasting blood glucose<br>Percentage of patients with HbA1c = 6.5%<br>Change from baseline in body mass index<br><br>Safety objectives: <br>the incidence of self reported hypoglycemic events<br>the incidence of patients requiring rescue for severe, persistent hyperglycemia<br>the incidence of cases of pancreatitis confirmed by adjudication and the effect on pancreatic enzymes<br>the incidence of cases of thyroid treatment emergent adverse events and the effect on serum calcitonin<br>the incidence of dulaglutide anti drug antibodies <br>the incidence of allergic, hypersensitivity, and injection site reactions<br><br>PK/PD:<br>Characterization of the PK of dulaglutide and the relationship between dulaglutide exposure and key safety and efficacy measures<br>;Timepoint(s) of evaluation of this end point: Week 26

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