E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes mellitus in children |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study) - 29 Oct 2016 Primary Objective: To meet the agreed PIP requirement for Europe that patients must be on metformin or have failed metformin to be in the study. If the patient failed metformin the reason must be documented. Also clarifies that in the case of emergency the investigator may unblind a patient without notifying sponsor first.
A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study) (1.1) - 23Mar2016 Primary Objective: The purpose of this addendum is to specify the PK collection schedule and analysis plan for the approximately 20 patients participating in this more intense PK sampling. |
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E.3 | Principal 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
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
E.5.2 Secondary End Points Change from baseline in HbA1c Change from baseline in fasting blood glucose Percentage of patients with HbA1c ≤ 6.5% Change from baseline in body mass index
Safety objectives: the incidence of self reported hypoglycemic events the incidence of patients requiring rescue for severe, persistent hyperglycemia the incidence of cases of pancreatitis confirmed by adjudication and the effect on pancreatic enzymes the incidence of cases of thyroid treatment emergent adverse events and the effect on serum calcitonin the incidence of dulaglutide anti drug antibodies the incidence of allergic, hypersensitivity, and injection site reactions
PK/PD: Characterization of the PK of dulaglutide and the relationship between dulaglutide exposure and key safety and efficacy measures
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Canada |
China |
India |
Mexico |
Saudi Arabia |
Turkey |
United States |
France |
Germany |
Hungary |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |