Diabetes Mellitus, Type 2Phase 2NCT00675857
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
A Phase 2 study testing NC-503 (eprodisate disodium) in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Bellus Health Inc. - a GSK company at 21 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 95 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- What is being tested?
- NC-503 (eprodisate disodium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 21 sitesCanada
- Study dates
- Apr 2008to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Canada21 sites
Study site
Calgary, Alberta, T3B 0M3
Study site
Chicoutimi, Quebec, G7H 5H6
Study site
Etobicoke, Ontario, M9R 4E1
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Laval, Quebec, H7T 2P5
Study site
London, Ontario, N6A 4V2
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H2W 1T7
Study site
Montreal, Quebec, H3A 1A1
Study site
Montreal, Quebec, H3H 2L9
Study site
Montreal, Quebec, H3N 1S4
Study site
Oakville, Ontario, L6H 3P1
Study site
Ottawa, Ontario, K1H 1A2
Study site
Ottawa, Ontario, K1K 4L2
Study site
Québec, Quebec, G1V 4G5
Study site
Sherbrooke, Quebec, J1G 1B8
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Thornhill, Ontario, L4J 8L7
Study site
Toronto, Ontario, M4R 2G4
Study site
Toronto, Ontario, M5C 2T2
Study site
Winnipeg, Manitoba, R3E 3P4
About this study
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
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.
Read the detailed description
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- Being tested
- NC-503 (eprodisate disodium), placebo
- Keywords
- Type II diabetes, Metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC-503 (eprodisate disodium)Drug
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
placeboOther
Dosage: 4 capsules BID for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Other: placebo |
| B | Active comparator | Not described Receives: Drug: NC-503 (eprodisate disodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 26 in HbA1c levels
Measured: 26 weeks
Secondary outcomes (3)
Change in HbA1c levels
Measured: 26 weeks
The rate of achieving glycemic control
Measured: 26 weeks
Change in fasting serum glucose levels
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Louis Chiasson, MD, Principal investigator, Hotel-Dieu du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675857
- Sponsor's protocol ID
- CL-503011
- Status last verified
- Aug 2010
- First submitted
- 8 May 2008
- Last updated
- 24 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00675857
- Acronym / sponsor ID
- CL-503011
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Syndrome X
- Keywords
- Type II diabetes, Metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Other: placebo |
| B | Active comparator | Drug: NC-503 (eprodisate disodium) |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC-503 (eprodisate disodium)capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks | Drug | B |
| placeboDosage: 4 capsules BID for 26 weeks | Other | A |
Primary outcome
Change from baseline to Week 26 in HbA1c levels
Time frame: 26 weeks
3 secondary outcomes
Change in HbA1c levels
Time frame: 26 weeks
The rate of achieving glycemic control
Time frame: 26 weeks
Change in fasting serum glucose levels
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Chiasson, MD principal investigator
Hotel-Dieu du Centre Hospitalier de l'Université de Montréal
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NC-503 (eprodisate disodium) in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome X, run by Bellus Health Inc. - a GSK company at 21 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 26 in HbA1c levels (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.