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

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

Official Title
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A Phase IIa Study of the Safety and Clinical Proof-of-concept of NC-503 (Eprodisate Disodium) in Patients With Type II Diabetes and Features of Metabolic Syndrome

Conditions
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Diabetes Mellitus, Type 2, Metabolic Syndrome X

Intervention / Treatment
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* Drug: NC-503 (eprodisate disodium)
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Other: placebo<br>* Dosage: 4 capsules BID for 26 weeks<br>|
| Active Comparator: B<br> | Drug: NC-503 (eprodisate disodium)<br>* capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 26 in HbA1c levels |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels |  | 26 weeks | 
| The rate of achieving glycemic control |  | 26 weeks | 
| Change in fasting serum glucose levels |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II diabetes, Metabolic syndrome