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

Phase 2TerminatedNCT00806585

Merck Sharp & Dohme LLC620 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

620

Conditions

Type 2 Diabetes Mellitus Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12

Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.

Time frame: Baseline and Week 12

Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12

Time frame: Baseline and Week 12

Secondary Outcomes

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration

Time frame: Baseline and Week 12

Change From Baseline in Body Weight at Week 24

Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.

Time frame: Baseline and Week 24

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration

Time frame: Baseline and Week 24