Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT00976495
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
* Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
* Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and \< 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and \< 105 mmHg
* C-peptide ≥ 0.8 ng/mL
* Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula \> 60 mL/min/1.73m² and \< 150 mL/min/1.73m²
* Urine albumin:creatinine ratio (UACR) \< 300 mg/g
* BMI ≤ 45.0 kg/m2
Exclusion Criteria:
* Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
* History of adverse reaction to radio-contrast dye
* Allergy or contraindication to use of thiazide diuretics
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 1.5X ULN
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00976495
Study Brief:
Protocol Section:
NCT00976495