Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
Status and phase
Terminated
Phase 2
Conditions
Hypertension
Type 2 Diabetes Mellitus
Treatments
Drug: Comparator: Placebo
Drug: MK-0736
Drug: Comparator: HCTZ
Details and patient eligibility
About
The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.
Enrollment
620 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Must be 18 to 75 years of age
- Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
- Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
- LDL-C < 140 mg/dL
- On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
Exclusion criteria
- History of Type I Diabetes mellitus or ketoacidosis
- Patients taking 3 or more blood pressure lowering medications
- Have severe chronic heart failure
- History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
- History of cancer within the last 5 years
- Human immunodeficiency virus (HIV) Positive
- Have received treatment with any investigational drugs within the past 30 days
- History of alcohol or drug abuse within the past 3 years
- Body Mass Index ( BMI) >= 41 kg/m2
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
620 participants in 5 patient groups, including a placebo group
MK-0736 0.5 mg
Experimental group
Description:
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
Treatment:
Drug: MK-0736
MK-0736 2.0 mg
Experimental group
Description:
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
Treatment:
Drug: MK-0736
MK-0736 8.0 mg
Experimental group
Description:
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
Treatment:
Drug: MK-0736
HCTZ 12.5 mg → MK-0736 8.0 mg
Active Comparator group
Description:
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
Treatment:
Drug: Comparator: HCTZ
Drug: MK-0736
Placebo
Placebo Comparator group
Description:
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
Treatment:
Drug: Comparator: Placebo
Trial contacts and locations
0
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems