Opening Hours : Monday - Friday from 8:30am to 5:00pm
  Contact : (972) 353-8616

Current Trials

Current Trials

The facility is the selected site for two clinical trials (IRB Approved) as under.

I. Study Title – A Study to Evaluate the effect of long term treatment with Drug X in the Incidence of Major Adverse Cardiovascular Events
IRB # 28850/347 | Sponsor: Eisai,Inc. | Principal Investigator: Jalil A Khan | Site # 1583.

II. Study Title – A comparative study to evaluate cardiovascular safety of Insulin in subjects with Diabetes at type 2 high risk of CVS Events.
IRB # 4375-084 | Sponsor: Novo Nordisk| Principal Investigator: Jalil A Khan | Site # 831

RECRUITING CLINICAL TRIALS

Our research center has many ongoing IRB APPROVED clinical trials targeted to various ailments and conditions. Your eligibility for a study is based on the study requirements.
If you choose to participate, there is no cost to you during the study. Furthermore, all of the following services are provided at no cost to you.

  • Board certified Physician’s Free clinical Assessments
  • Study related medical care
  • Investigational medication
  • Study related testing
  • Compensation for time and trave
  • No insurance required

 

For more information, please contact: DR MARIA AZIZ ,972-353-8616 Ext 105 or email primedcareresearch@gmail.com

 

Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: PRI-MED CARE,LEWISVILLE,TX

CURRENT TRIALS DETAILS

CURRENT TRAIL SNAPSHOT

PHASE-3
GENDER -MALE /FEMALE
AGE ->40Y
OVERALL STATUS- RECRUITING

Overview

 

RESEARCH STUDY SUMMARY

A Phase 3 clinical study of ORAL DRUG X for patients with Type 2 Diabetes Mellitus with established vascular disease in the coronary ,cerebral or peripheral arteries.

 

PURPOSE

This study will evaluate the efficacy and safety of ORAL DRUG X in participants with type 2 diabetes mellitus with established vascular disease in the coronary ,cerebral or peripheral arteries

 

Study Type: Interventional
Overall Recruitment Status: Recruiting
Study Start Date: JUNE 2016
Estimated Study Completion Date: JUNE 2021
Estimated Primary Completion Date: JULY 2021(Final data collection date for primary outcome measure)

 

Inclusion Criteria:

  • Male or Female subjects > 40 yrs of age with a Diagnosis of T2DM
  • HbA1c at screening visit of 7.0-10.5 % on stable allowable anti –hyperglycemic agents or on no background AHA for at least 8 weeks prior to the screening visit
  • Evidence or a history of atherosclerosis involving the coronary ,cerebral or peripheral vascular systems (Coronary artery disease –Myocardial infarction ,history of coronary revascularization ,PCI,CABG,Ischaemic stroke,carotid revascularization,Peripheral arterial disease,Subjects with multiple cardiovascular qualifying events are also eligible for enrollment)

 

Exclusion Criteria:

  • Sitting systolic blood pressure >160 mmHg and /or Diastolic blood pressure > 90 mm Hg at the screening visit
  • Fasting triglycerides >600 mg/dl at the screening visit
  • Fasting plasma or finger stick glucose >270 mg/dl
  • Heart Failure –Class IV ,NYHA classification
  • Hemoglobin <10g/dl
  • STSH, outside the reference range
  • Active, obstructive uropathy or indwelling urinary catheter.

CURRENT TRAIL SNAPSHOT

PHASE- 4
GENDER -MALE /FEMALE
AGE -18-85Y
OVERALL STATUS- RECRUITING

Overview

 

RESEARCH STUDY SUMMARY

Randomized trial assessing the effectiveness of the use designed study algorithm, utilizing paper or digitized methods, versus standard of care in a real-world setting in TDM PATIENTS on Prandial Insulin prescription .

 

PURPOSE

This study will evaluate the efficacy of use of study algorithm with digitalized tools or Paper tools with Prandial Insulin prescription ( Covered by HUMANA INSURANCE)

 

Overall Recruitment Status: Recruiting

 

Study duration:
The maximum study duration will be 52 weeks per patient.

 

Key dates:
Protocol approval: January 29, 2016, First patient in: May 9, 2016, Last patient in: February 10, 2017. The maximum recruitment period is nine months.

 

Target population:

  1. Patients with Type 2 diabetes mellitus (T2DM), as defined by World Health Organization (WHO) criteria
  2. Are Between the ages of 18 and 85 years inclusive
  3. Have been treated for at least 90 days with greater than or equal to 40 units of long-acting insulin (e.g., insulin glargine, insulin deter, insulin degludec, or U-300 insulin glargine) in combination with or without anti-hyperglycemic agents
  4. Have a hemoglobin A1c (HbA1c) value greater than or equal to 8 percent within 12 weeks of study entry
  5. In the opinion of the investigator, requires addition of prandial insulin

 

Exclusion Criteria

  1. Have had one or more episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar non-ketotic syndrome (HHNS) in the past 26 weeks
  2. Have a hist of renal transplantation or are currently renal dialysis
  3. Have active malignancy
  4. Are unable and/or unwilling to provide informed consent, make themselves available for the duration of the study or abide by study procedures
  5. Use of neutral protamine hagedorn (NPH) insulin within the past 12 weeks
  6. Pregnant or planning to become pregnant
  7. Glucocorticoid therapy: Receiving chronic (lasting longer than two weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within two weeks immediately before first visit
  8. Patients on insulin pu,p therapy
  9. Patients on prandial insulin within the past 12 weeks
  10. For diabetes patients or caregivers, any individuals physically (e.g., with hand impairment, blindness or visual impairment) or mentally unable to use the tools on their own (AUTONOMY cohort only)
  11. Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study