Diabetes Mellitus, Type 2, Metabolic Syndrome X
Conditions
Keywords
Type II diabetes, Metabolic syndrome
Brief 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.
Detailed description
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
Interventions
DRUGNC-503 (eprodisate disodium)
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
OTHERplacebo
Dosage: 4 capsules BID for 26 weeks
Sponsors
Bellus Health Inc. - a GSK company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 95 Years
Healthy volunteers
No
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 * Patients who have an increased red blood cell (RBC) turn-over or Thalassemia or anemia * Known HIV or history of viral hepatitis type B or C. * Any type of diabetes other than Type 2 diabetes * Significant hepatic enzyme elevation * Body mass index (BMI) of \> 40kg/m2 * Current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 26 in HbA1c levels | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels | 26 weeks |
| The rate of achieving glycemic control | 26 weeks |
| Change in fasting serum glucose levels | 26 weeks |
Countries
Canada
Outcome results
None listed