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).
- Conditions
- Type 2 diabetes mellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-000361-22-GB
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 150
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
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. Except for bolus insulin, all other diabetic medications must have been stopped at least 3 months before the screening visit. Patients should not have received bolus insulin within 6 weeks of the screening visit, except as rescue treatment for management of acute medical conditions for a maximum of 14 days.
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