A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— AWARD-PEDS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963766
• Other study ID #: 14171
• Secondary ID: H9X-MC-GBGC2016-
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2016
• Est. completion date: January 12, 2022

Study information

• Verified date: June 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 12, 2022
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Have type 2 diabetes, 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.

• Have HbA1c >6.5% to =11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to =9%.

• Have a BMI (body mass index) >85 percentile for age, gender and body weight =50 kilograms (110 pounds).

Exclusion Criteria:

• Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.

• A history of, or at risk for pancreatitis.

• 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 milliliter (pg/ml) at screening.

• A systolic blood pressure of =160 millimeters of mercury (mmHg) or diastolic =100 mmHg.

• Active or treated cancer.

• A blood disorder where an accurate HbA1c may not be obtainable.

• A female of childbearing age, sexually active and not on birth control.

• Pregnant or plan to be pregnant during the study, or breastfeeding.

• Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).

• Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.

• Using prescription weight loss medications in the last 30 days, or plan to use.

• Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dulaglutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Brazil	Hospital PUC-CAMPINAS	Campinas	Sao Paulo
Brazil	Centro de Pesquisas em Diabetes	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto da Criança com Diabetes	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da FMRP	Ribeirão Preto	São Paulo
Brazil	Instituto Estadual de Diabetes e Endocrinologia	Rio de Janeiro	RJ
Brazil	CPCLIN	São Paulo	SP
Brazil	Hospital da Clinicas da Faculdade de Medicina da USP	São Paulo	SP
Brazil	UNIFESP - Escola Paulista de Medicina	São Paulo
France	Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre	Le Kremlin Bicetre
France	Hopital Robert Debre	Paris
Germany	Praxis Dr. med. Landers	Mayen	Rheinland-Pfalz
Germany	RED-Institut GmbH	Oldenburg in Holstein	Schleswig Holstein
Germany	Zentrum für klinische Studien	Sankt Ingbert	Saarland
Hungary	Heim Pal Gyermekkorhaz	Budapest
India	Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre	Ahmedabad	Gujarat
India	M S Ramaiah Medical College Hospital	Bangalore	Karnataka
India	Manipal Hospital	Bangalore	Karmnataka
India	Post Graduate Institute of Medical Education & Research	Chandigarh	Punjab
India	Apollo Gleneagles Hospitals Kolkata	Kolkata	West Bengal
India	Park Clinic	Kolkata	West Bengal
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Banaras Hindu University - BHU	Varanasi	Uttar Pradesh
Mexico	Health Pharma Professional Research, S.A. de C.V.	Mexico City	Federal District
Mexico	Centro Medico San Francisco	Monterrey	Nuevo Leon
Mexico	Hospital Angeles Puebla	Puebla
Mexico	Cli-nica Hospital Cemain	Tampico	Tamaulipas
Mexico	Arke Estudios Clinicos S.A. de C.V.	Veracruz
Mexico	Centro de Inv. Medica de Occidente, SC	Zapopan	Jalisco
Puerto Rico	Centro de Diabetes y Endocrinologia Pediatrica de PR	Bayamon
Saudi Arabia	King Salman bin Abdulaziz Hospital - Diabetic Center	Riyadh
Saudi Arabia	King Saud University Hospital	Riyadh
Turkey	Ankara University Medicine Hospital	Ankara	Mamak
Turkey	Sami Ulus Education & Research Hospital	Ankara
Turkey	Duzce University Medical Faculty	Duzce
Turkey	Ondokuz Mayis University Medical Faculty	Samsun
United Kingdom	St James's University Hospital	Leeds	West Yorkshire
United Kingdom	Alder Hey Children's Hospital	Liverpool	Lancashire
United States	Advanced Research Center	Anaheim	California
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	CAMC Institute	Charleston	West Virginia
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	ECU Pediatric Specialty Care	Greenville	North Carolina
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Division of Endocrinology, Diabetes, and Metabolism	Los Angeles	California
United States	Childrens Hospital of Orange County	Orange	California
United States	Florida Center for Endocrinology & Metabolism	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Childrens Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Center of Excellence in Diabetes & Endocrinology	Sacramento	California
United States	Rady Childrens Hospital - San Diego	San Diego	California
United States	JC Cabaccan	San Jose	California
United States	Seattle Children's Hospital Research Foundation	Seattle	Washington
United States	Multicare Health System	Tacoma	Washington
United States	University of Arizona	Tucson	Arizona
United States	Touro University	Vallejo	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  France,  Germany,  Hungary,  India,  Mexico,  Puerto Rico,  Saudi Arabia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).	Baseline, Week 26
Secondary	Change From Baseline in HbA1c (Individual Doses) at Week 26	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).	Baseline, Week 26
Secondary	Change From Baseline in Fasting Blood Glucose (FBG) at Week 26	Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).	Baseline, Week 26
Secondary	Percentage of Participants With HbA1c =7.0%	The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.	Week 26
Secondary	Change From Baseline in Body Mass Index (BMI) at Week 26	BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%).	Baseline, Week 26
Secondary	Percentage of Participants With Self-Reported Events of Hypoglycemia	Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL.	Week 26
Secondary	Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia	Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.	Week 26
Secondary	Number of Participants With Adjudicated Pancreatitis	The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Week 26
Secondary	Change From Baseline in Pancreatic Enzymes at Week 26	Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.	Baseline, Week 26
Secondary	Number of Participants With Thyroid Treatment-Emergent Adverse Events	Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.	Week 26
Secondary	Change From Baseline in Serum Calcitonin at Week 26	Change from Baseline in Serum Calcitonin was evaluated.	Baseline, Week 26
Secondary	Percentage of Participants With Allergic, Hypersensitivity Reactions	The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Week 26
Secondary	Percentage of Participants With Injection Site Reactions	The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Week 26
Secondary	Number of Participants With Anti-Dulaglutide Antibodies	Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.	Baseline through Week 56
Secondary	Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)	PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.	Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
Secondary	PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]	PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.	Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit

External Links

•   A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)