Recruiting
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)
H9X-MC-GBGC - ClinicalTrials.gov - NCT02963766
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.
How long will I be in the trial?
Your participation could last up to 60 weeks and include 8 visits to the study center
Recruiting
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)
H9X-MC-GBGC - ClinicalTrials.gov - NCT02963766
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.
How long will I be in the trial?
Your participation could last up to 60 weeks and include 8 visits to the study center
Key Requirements
Age :
10-17
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
10-17
Sex
All
Participants must
Pediatric participant (child or teen) must have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin
Pediatric participant must be on a stable does of metformin and/or basal insulin for at least 8 weeks
Participants must NOT
Pediatric participant must not have type 1 diabetes
Female participant who are having menstrual period must be on birth control if sexually active
Pediatric participant must not be taking any medicine for diabetes other than metformin and/or basal insulin and must have stopped any other diabetic medicine at least 3 months prior to starting the first study visit
Pediatric participant must not have taken oral steroids within the last 60 days
Pediatric participant must not have used prescription weight loss medications in the last 30 days, or plan to use
Trial Summary
Conditions the trial is for
Type 2 Diabetes, Pediatric Type 2 Diabetes
What the trial is testing?
Dulaglutide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
150
Trial Dates
December 2016 - January 2022
Trial Phase
3
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Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
10-17
Sex
All
Participants must
Pediatric participant (child or teen) must have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin
Pediatric participant must be on a stable does of metformin and/or basal insulin for at least 8 weeks
Participants must NOT
Pediatric participant must not have type 1 diabetes
Female participant who are having menstrual period must be on birth control if sexually active
Pediatric participant must not be taking any medicine for diabetes other than metformin and/or basal insulin and must have stopped any other diabetic medicine at least 3 months prior to starting the first study visit
Pediatric participant must not have taken oral steroids within the last 60 days
Pediatric participant must not have used prescription weight loss medications in the last 30 days, or plan to use
Trial Summary
Conditions the trial is for
Type 2 Diabetes, Pediatric Type 2 Diabetes
What the trial is testing?
Dulaglutide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
150
Trial Dates
December 2016 - January 2022
Trial Phase
3
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Trial Locations
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