[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

+1-877-825-3327

Email address

medinfoUS@takeda.com

Condition

Diabetes Mellitus, Type 2

Treatment type

Interventional

Investigational product

Alogliptin

Phase

Phase 4

Sponsor

Takeda

ClinicalTrials.gov identifier

NCT03499704

Study number

Alogliptin-Pio-4001

Understanding clinical trials

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About the study

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 52.

Who can take part?

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

Inclusion criteria
  1. NHLBI) / American Heart Association (AHA); and International Association for the Study of Obesity (IASO). If any 3 of the following 5 risk factors are present, metabolic syndrome can be considered: - High waist circumference: male >=90 centimeter (cm), female >=85 cm. - High TGs (drug treatment for high TGs is an alternate indicator): >=150 mg/dL (1.7 millimole per liter [mmol/L]). - Low HDL-C (drug treatment for low HDL-C is an alternate indicator): <40 mg/dL (1.0 mmol/
  2. L) in males, <50 mg/dL (1.3 mmol/
  3. L) in females. - High blood pressure (antihypertensive drug treatment in a participant with a history of hypertension is an alternate indicator): Systolic >=130 millimeter of mercury (
  4. mmHg) and/or diastolic >=85 mmHg. - High fasting glucose (drug treatment of high glucose is an alternate indicator): >= 100 mg/dL. 3. Has been receiving a stable dose of alogliptin + metformin therapy with diet and exercise for >=3 months prior to randomization. 4. Has a HbA1c value between 7.0 to 11% inclusively within 7 days of randomization via central laboratory test.
Exclusion criteria
  1. TZD) or sodium-glucose co-transporter-2 (SGLT-
  2. 2) inhibitor within 6 months prior to randomization. 2. Has type 1 diabetes, diabetic ketoacidosis, diabetic coma or diabetic pre-coma. 3. The use of any medications that is, oral or systemically injected glucocorticoids (including intra-articular injection), weight-loss drugs, insulin or other anti-diabetic drugs except alogliptin and metformin, within 3 months prior to randomization. Strong Cytochrome P450 2C8 (
  3. CYP2C8) inhibitors (example, gemfibrozil, montelukast, quercetin,
  4. phenelzine) and CYP2C8 inducers (example,
  5. rifampin) that in the opinion of the Investigator or Sponsor require treatment contraindicated during the study. The diuretics, angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (
  6. ACE) -inhibitors and nonsteroidal anti-inflammatory drugs (
  7. NSAIDs) are to be used per product label with close monitoring under Investigator's supervision. 4. Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc. 5. Has a history of alcohol abuse within 2 years prior to randomization.

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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