Back to resultsA Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Metabolic Syndrome X
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
NC-503 (eprodisate disodium)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type II diabetes, Metabolic syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to Week 26 in HbA1c levels
Secondary Outcome Measures
Change in HbA1c levels
The rate of achieving glycemic control
Change in fasting serum glucose levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00675857
Brief Title
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
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bellus Health Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Metabolic Syndrome X
Keywords
Type II diabetes, Metabolic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NC-503 (eprodisate disodium)
Intervention Description
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Dosage: 4 capsules BID for 26 weeks
Primary Outcome Measure Information:
Title
Change from baseline to Week 26 in HbA1c levels
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c levels
Time Frame
26 weeks
Title
The rate of achieving glycemic control
Time Frame
26 weeks
Title
Change in fasting serum glucose levels
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Chiasson, MD
Organizational Affiliation
Hotel-Dieu du Centre Hospitalier de l'Université de Montréal
Official's Role
Principal Investigator
Facility Information:
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 0M3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 4L2
Country
Canada
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4R 2G4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T7
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3H 2L9
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3N 1S4
Country
Canada
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 1B8
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
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A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
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