Main Content

Type 2 diabetes with uncontrolled hypertension on ACEI/ARB+ one additional antihypertensive

Project Name:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of XXXX in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

Institutions involved: Aggarwal and Associates Ltd., Recherches Cliniques Theradev, Manna Research, The Medical Arts Health Research Group, Recherche GCP Research, Dr. A. Nayar Medical Prof. Corp., Victoria Clinical Research Inc., G.A. Research Associates Ltd.

Investigators involved: Naresh Aggarwal, Didier Fay, Ben Lasko, Tersia Lichtenstein, Giuseppe Mazza, Arun Nayar, Lucretia van den Berg, Daniel Landry

City: Brampton, Granby, Toronto, Kelowna, Montreal, Saskatoon , Victoria, Moncton

Province: ON, QC, BC, SK, NB

Funding source: Pharmaceutical Sponsor

Project start date: Ongoing

Project end date: March 2013

Inclusion criteria:
• Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
• Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
• Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
• C-peptide ≥ 0.8 ng/mL
• Body Mass Index ≤ 45.0 kg/m2
• Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Brief abstract of project and relevance:
Study Type: Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Primary Outcome Measures:
• Change from baseline in seated systolic blood pressure after 12 weeks of treatment
• Change from baseline in Glycosylated hemoglobin (HbA1c) after 12 weeks of treatment
Secondary Outcome Measures:
• Change from baseline in 24-hr ambulatory systolic blood pressure after 12 weeks of treatment
• Change in 24-hr ambulatory diastolic blood pressure after 12 weeks of treatment
• Change in serum uric acid after 12 weeks of treatment

Ethical Approval: Yes

Rationale for posting on the Canadian Diabetes Association website: for recruitment

Contact Information: If you wish to find out more information about our trial, or if you are interested in participating, please contact the person at the location that is most convenient for you.

Investigator Name: Naresh Aggarwal
Contact Name: Paula Borg
Aggarwal and Associates Ltd.
490 Bramalea Road 201
Brampton, ON L6T 0G1
905-458-9033

Investigator Name: Didier Fay
Contact Name: Claudette Robert
Recherches Cliniques Theradev
4 Robinson Road
Granby, QC J2G 8Z9
450-378-8805

Investigator Name: Daniel Landry
Contact Name: Dr. Daniel Landry
G.A. Research Associates Ltd.
1789 Mountain Road; Suite 206
Moncton NB E1G 1A7
506-852-9865

Investigator Name: Ben Lasko
Manna Research 2291 Kipling Avenue; Unit 117B
Toronto ON M9W 4L6
416-740-2895

Investigator Name: Tersia Lichtenstein
Contact Name: Florence Hunter
The Medical Arts Health Research Group
1605 Gordon Drive
Kelowna, BC V1Y 3G8
250-763-1791

Investigator Name: Giuseppe Mazza
Contact Name: Dr. Giuseppe Mazza
Recherche GCP Research
1021 Jean Talon East; Suite 200
Montreal QC H2R 1V6
514-787-1818

Investigator Name: Arun Nayar
Contact Name: Geeta Nayar
Dr. A. Nayar Medical Prof. Corp.
125-750 Spadina Cres. E
Saskatoon, SK
S7K 3H3
306-652-5414

Investigator Name: Lucretia van den Berg
Contact Name: Veronica Anthony
Victoria Clinical Research Inc.
109-1026 Johnson Street
Victoria, BC
V8V 3N7
250-213-5011