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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome X
• Interventions: Other: placebo; Drug: NC-503 (eprodisate disodium)

• Registration Number: NCT00675857
• Lead Sponsor: Bellus Health Inc. - a GSK company

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-12
• Primary Completion: 2010-01
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	placebo	-
B	NC-503 (eprodisate disodium)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 26 in HbA1c levels	26 weeks

Secondary Outcome Measures

Name	Time	Method
The rate of achieving glycemic control	26 weeks
Change in fasting serum glucose levels	26 weeks
Change in HbA1c levels	26 weeks