A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes

Bellus Health

Status and phase

Completed

Phase 2

Conditions

Metabolic Syndrome X

Diabetes Mellitus, Type 2

Treatments

Drug: NC-503 (eprodisate disodium)

Other: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00675857

CL-503011

Details and patient eligibility

About

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.

Full description

Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.

Enrollment

200 estimated patients

Sex

All

Ages

30 to 95 years old

Volunteers

No Healthy Volunteers

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