Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-0736 0.5 mg

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).

Group Type EXPERIMENTAL

MK-0736

Intervention Type DRUG

MK-0736 2.0 mg

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).

Group Type EXPERIMENTAL

MK-0736

Intervention Type DRUG

MK-0736 8.0 mg

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).

Group Type EXPERIMENTAL

MK-0736

Intervention Type DRUG

HCTZ 12.5 mg → MK-0736 8.0 mg

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).

Group Type ACTIVE_COMPARATOR

MK-0736

Intervention Type DRUG

Comparator: HCTZ

Intervention Type DRUG

Placebo

One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Interventions

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MK-0736

Intervention Type DRUG

Comparator: Placebo

Intervention Type DRUG

Comparator: HCTZ

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No