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

Phase 2

Terminated

• Conditions: Hypertension; Type 2 Diabetes Mellitus
• Interventions: Drug: MK-0736

• Registration Number: NCT00806585
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Results First Submitted: 2013-10-18
• Results First Submitted QC: 2013-10-18
• Results First Posted: 2013-12-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 620

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0736 0.5 mg	MK-0736	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).
MK-0736 2.0 mg	MK-0736	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).
MK-0736 8.0 mg	MK-0736	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).
HCTZ 12.5 mg → MK-0736 8.0 mg	MK-0736	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12	Baseline and 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.
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12	Baseline and 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 the last 5 measurement was recorded.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12	LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24	Baseline and Week 24	HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration
Change From Baseline in Body Weight at Week 24	Baseline and 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.