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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00806585
First received: December 10, 2008
Last updated: June 15, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypertension
 Drug: MK0736
Drug: Comparator: Placebo
Drug: Comparator: HCTZ
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Reduction in systolic and diastolic blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HbA1C compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • LDL-C compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 602
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
HCTZ
 Drug: Comparator: HCTZ
HCTZ 12.5mg once daily for 12 weeks then MK0736 8 mg once daily for 64 weeks.
Experimental: 2
MK0736
 Drug: MK0736
Arm 2: MK0736 8 mg tablets once daily for 76 weeks. Arm 3: MK0736 2 mg tablets once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks. Arm 4: MK0736 0.5mg tablets taken once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks.
Experimental: 3
MK0736
 Drug: MK0736
Arm 2: MK0736 8 mg tablets once daily for 76 weeks. Arm 3: MK0736 2 mg tablets once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks. Arm 4: MK0736 0.5mg tablets taken once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks.
Experimental: 4
MK0736
 Drug: MK0736
Arm 2: MK0736 8 mg tablets once daily for 76 weeks. Arm 3: MK0736 2 mg tablets once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks. Arm 4: MK0736 0.5mg tablets taken once daily for 24 weeks then MK0736 8 mg tablets taken once daily for 52 weeks.
Placebo Comparator: 5
Placebo
 Drug: Comparator: Placebo
MK0736 or HCTZ placebo tablets taken for 76 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 to 75 years of age
  • Type 2 Diabetes Mellitus (HbA1c: 7 to 10%)
  • Hypertension: DBP (85 to 99 mm Hg) and 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
  • 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
  • BMI >= 41 kg/m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806585

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00806585     History of Changes
Other Study ID Numbers: 2008_600, MK0736-007
Study First Received: December 10, 2008
Last Updated: June 15, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Hydrochlorothiazide
Angiotensin Receptor Antagonists
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013