[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

800-633-1610

Email address

Contact-US@sanofi.com

Condition

Type 1 Diabetes Mellitus

Treatment type

Interventional

Investigational product

Background therapy: Rapid acting insulin analogs

Phase

Phase 4

Sponsor

Sanofi

ClinicalTrials.gov identifier

NCT04075513

Study number

LPS14947

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About the study

Primary Objective: To demonstrate the noninferiority of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL on glycemic control and variability in participants with diabetes mellitus Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring (CGM) To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL

Who can take part?

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

Inclusion criteria
  1. T1DM) - Participants treated with multiple daily injections (
  2. MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year - HbA1c ≥ 7% (48 mmol/
  3. mol) and ≤ 10% (86 mmol/
  4. mol) at screening
Exclusion criteria
  1. rapid) within 30 days prior to screening - Participants having received basal insulin dose ≥0.6 U/kg body weight within 30 days prior to screening - Participants having received any glucose lowering drugs (including any premixed insulins,human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening - End stage renal disease or on renal replacement treatment - Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to
  2. screening) or planned: intravitreal injections or laser or vitrectomy surgery Body weight change ≥5 kg within 3 months prior to screening The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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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