Clinical trial NCT00675857: A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome X
Keywords: Type II diabetes
Metabolic syndrome
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to Week 26 in HbA1c levels
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in HbA1c levels
timeFrame: 26 weeks
measure: The rate of achieving glycemic control
timeFrame: 26 weeks
measure: Change in fasting serum glucose levels
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Etobicoke
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Québec
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Hotel-Dieu du Centre Hospitalier de l'Université de Montréal
name: Jean-Louis Chiasson, MD
role: PRINCIPAL_INVESTIGATOR
References: