A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes (NCT00675857) | Clinical Trial Compass
CompletedPhase 2
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Canada200 participantsStarted 2008-04
Plain-language summary
The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.
Who can participate
Age range30 Years – 95 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age and gender eligibility: 30 years and older
* Diagnosis of Type 2 diabetes mellitus
* Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the Screening visit
* Patients must have HbA1C level between 7.0-10.0 %, inclusively at screening
* The participant must have central obesity (Waist circumference) defined per country/ethnic group: Europids: men ≥ 94 cm, women ≥ 80 cm; South Asian, Chinese \& Japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
* Reduced HDL cholesterol ≤ 1.0 mmol/L
* Hypertriglyceridemia ≥ 1.7 mmol/L or treatment for dyslipidemia
* Hypertension: ≥ 130/85 mm Hg blood pressure or treatment with antihypertensive medication.
* Patients must have a Glomerular Filtration Rate (GFR) of ≥ 60 mL/min, and no history of dialysis.
Exclusion Criteria:
* Patients having received insulin, thiazolidinediones (TZDs) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
* Has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease
* Pati…