[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-317-615-4559

Condition

Type 2 Diabetes

Treatment type

Interventional

Investigational product

Dulaglutide

Phase

Phase 3

Sponsor

Eli Lilly and Company

ClinicalTrials.gov identifier

NCT02963766

Study number

H9X-MC-GBGC

Understanding clinical trials

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. 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.
  2. 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%.
  3. Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).
Exclusion criteria
  1. Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis after taking diabetes medication.
  2. A history of, 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 milliliter (pg/ml) at screening.
  4. A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100mmHg.
  5. Active or treated cancer.
  6. A blood disorder where an accurate HbA1c may not be obtainable.
  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 within the past year or 1000 micrograms fluticasone propionate per day.
  11. Using prescription weight loss medications in the last 30 days, or plan to use.
  12. Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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