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Diabetes Mellitus Type 2Phase 2NCT00157729

MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)

A Phase 2 study testing pyridoxal-5'-phosphate with and without ACE inhibitor in people with Diabetes Mellitus Type 2 and Hypertension, run by Medicure at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether MC-1 alone and in combination with an ACE inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with diabetes Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
pyridoxal-5'-phosphate with and without ACE inhibitor
How many people
160 participants
Where
1 siteCanada
Study dates
Aug 2004to Jul 2005
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus treated with diet, oral hypoglycaemic agents or insulin) for a minimum of 2 years (24 months)
  • Systolic hypertension prior to entry into the washout period. At Visit 3 patients must have a mean sitting systolic blood pressure in the range of 140-180 mmHg, and a mean sitting diastolic blood pressure <110mmHg
  • A mean daytime ambulatory systolic blood pressure greater than or equal to 135 mm Hg at baseline

Who cannot join

  • Poorly controlled type 2 diabetes mellitus (HbA1c ≥ 10%)
  • Secondary hypertension of any aetiology, such as renal artery stenosis, coarctation of the aorta or pheochromocytoma
  • History of malignant hypertension
  • Body mass index > 37
  • Single functioning kidney
  • Known sensitivity or intolerance to angiotensin-converting enzyme inhibitors
Show all 30Show fewer
  • History of angioedema
  • Known syncopal disorder
  • Pregnant woman or a woman of childbearing potential who is sexually active and not using an appropriate method of birth control (double barrier or oral contraceptives)
  • Concomitant therapy with any antihypertensive medications, including those used for indications other than hypertension (e.g., diuretics for any reason, minoxidil for hair loss, propranolol HCl for migraine, terazosin HCl for benign prostatic hyperplasia, 5-phosphodiesterase inhibitors (Viagra, Cialis, Levitra) within 48 hours of clinic visit, ACE-inhibitors for congestive heart failure, or any agent which could cause a change in blood pressure), except for stable doses of NSAIDs, or tricyclic agents taken at bedtime. Patients who are unwilling to discontinue these medications or patients in whom the Investigator feels it is clinically inappropriate to discontinue these medications should not participate in the study
  • Concomitant therapy with lithium and/or major psychotropic agents such as phenothiazines
  • Concomitant therapy with oral steroids or ACTH
  • Concomitant therapy with cold and/or flu medications containing sympathomimetic agents. Intermittent use of therapies containing ephedrine is permitted except within 72 hours of clinic visits for mean trough SiSBP
  • Concomitant therapy with any vitamin supplement that may contain pyridoxine or pyridoxine derivative such as pyridoxal phosphate or pyridoxal
  • Hypertension induced by oral contraceptives. Replacement hormones (thyroid, testosterone, estrogens) are permitted if the patient has been on a stable dose for at least three months
  • Existing symptomatic cerebro-vascular disease including previous transient ischemic attack (TIA) or stroke within 12 months prior to screening
  • Myocardial infarction, percutaneous coronary intervention and coronary artery bypass surgery within 6 months prior to screening
  • Clinically significant AV conduction disturbance, i.e., second or third degree AV block, sick sinus syndrome or clinically significant bradycardia (resting heart rate < 60 beats/minute) without a permanent pacemaker
  • Presence of atrial flutter or atrial fibrillation
  • Potentially life-threatening ventricular arrhythmias, decompensated valvular disease, presence of hemodynamically significant obstructive valvular disease, or cardiomyopathy
  • Serum potassium < 3.5 or > 5.5 mEq/L
  • The presence of severe hepatic impairment as manifested by AST (SGOT) > 2.5 times the upper limit of normal or ALT (SGPT) > 2.5 times the upper limit of normal
  • Any clinically significant laboratory value which in the Investigator's judgement could be clinically significant to the outcome of this study. This includes, but is not limited to, hematocrit, haemoglobin or platelet count
  • Any moderate to severe renal impairment, as manifested by serum creatinine more than 200 micromol/L
  • A history of clinically important gastrointestinal resection, malabsorption or cirrhosis of the liver
  • Any concurrent severe disease that, in the Investigator's judgement, could preclude participation or survival
  • Use of any investigational drug or device, or participation in any drug study during or within 30 days prior to baseline
  • Inability to be taken off of all current antihypertensive medications
  • Unwillingness or inability to give consent or to follow the protocol procedures
  • Arm circumference greater than 41 cm

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier Université Laval

    Sainte-Foy, Quebec, G1V 4G2

Other trials in Canada

About this study

Official title: Evaluation of the Effects of MC-1 Alone and in Combination With an ACE Inhibitor on Ambulatory Blood Pressure and Metabolic Function in Hypertensive Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine whether MC-1 alone and in combination with an ACE inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with diabetes

Read the detailed description

Hypertension is an extremely common co-morbid condition in diabetics, affecting up to 11 million patients, depending on obesity, ethnicity and age. Hypertension substantially increases the risk of both macrovascular and microvascular complications including stroke, coronary artery disease, peripheral vascular disease, retinopathy, nephropathy and possibly neuropathy.

In recent years, adequate data from well-designed randomized clinical trials have demonstrated the effectiveness of aggressive treatment of hypertension in reducing diabetic complications. In the epidemiological UK Prospective Diabetes Study (UKPDS), each 10 mmHg decrease in mean systolic blood pressure was associated with reductions in risk of 12% for any complication related to diabetes, 15% for deaths related to diabetes, 11% for myocardial infarction and 13% for microvascular complications. Currently the consensus guidelines recommend a blood pressure target of <130/80 mmHg in diabetic patients with hypertension, even though they recognize many people will require three or more drugs to reach this goal.

MC-1 is a naturally occurring metabolite of vitamin B6, and thus has very low toxicity. Evidence from pre-clinical studies suggests that MC-1 has beneficial effects on hypertension and metabolic dysfunction. This trial will assess the effects of MC-1 alone and MC-1 in combination with an ACE inhibitor compared to placebo on hypertension and parameters of metabolic function in type 2 diabetic patients.

Being tested
pyridoxal-5'-phosphate with and without ACE inhibitor
Keywords
Hypertension, antihypertensive agents, diabetes mellitus type 2, metabolic syndrome
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pyridoxal-5'-phosphate with and without ACE inhibitorDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects on blood pressure:

  2. Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on blood pressure as measured by mean daytime ambulatory systolic blood pressure.

  3. Effects on metabolic function:

  4. Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on metabolic function as measured by insulinemia, fasting serum glucose, glycated hemoglobin, and triglycerides.

Secondary outcomes (11)

  1. To compare the effects of the different treatment regimens as measured by:

  2. mean change from baseline in mean daytime ambulatory diastolic BP

  3. mean change from baseline in mean 24 hour and mean night-time ambulatory systolic BP

  4. mean changes from baseline in mean 24 hour, mean daytime and mean night-time pulse pressure

  5. mean changes from baseline in clinic trough sitting systolic BP (SiSBP)

  6. mean changes from baseline in mean 24 hour, and mean night-time ambulatory diastolic BP

  7. mean changes from baseline in clinic trough sitting diastolic BP (SiDBP)

  8. mean change in endothelial function as measured by mean changes in different markers such as ICAM-1, VCAM-1, E-selectin and albuminuria

  9. mean changes in C-reactive protein (CRP)

  10. mean changes in homocysteine

  11. mean changes in creatinine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Study completionJul 2005

Resources

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
Crossover
Masking
Double blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157729
Sponsor's protocol ID
MC6021-CL-04001
Status last verified
Oct 2006
First submitted
8 Sep 2005
Last updated
31 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pyridoxal-5'-phosphate with and without ACE inhibitor in people with Diabetes Mellitus Type 2 and Hypertension, run by Medicure at 1 site 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 3 inclusion and 30 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 31 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Effects on blood pressure:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00157729.

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 31 Oct 2006.

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