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
Email
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
Email

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

Enter your postal code to find the nearest site

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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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?