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

NCT00806585 | Terminated Phase 2 Results

• 3 other identifiers: 0736-007MK0736-0072008_600
• Study Type: interventional
• Target: 620
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Week 12

• Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) 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 the last 5 measurement was recorded.

  Baseline and Week 12

Secondary Outcomes (3)

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

  Baseline and Week 12

• Change From Baseline in Body Weight at Week 24

  Baseline and Week 24

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

  Baseline and Week 24

Study Arms (5)

MK-0736 0.5 mg

EXPERIMENTAL

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).

Drug: MK-0736

MK-0736 2.0 mg

EXPERIMENTAL

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).

Drug: MK-0736

MK-0736 8.0 mg

EXPERIMENTAL

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).

Drug: MK-0736

HCTZ 12.5 mg → MK-0736 8.0 mg

ACTIVE COMPARATOR

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).

Drug: MK-0736; Drug: Comparator: HCTZ

Placebo

PLACEBO COMPARATOR

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

Drug: Comparator: Placebo

Interventions

MK-0736 DRUG

HCTZ 12.5 mg → MK-0736 8.0 mg; MK-0736 0.5 mg; MK-0736 2.0 mg; MK-0736 8.0 mg

Comparator: Placebo DRUG

Placebo

Comparator: HCTZ DRUG

HCTZ 12.5 mg → MK-0736 8.0 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDevelopment@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 21, 2015
• Results First Posted: December 11, 2013

Record last verified: 2015-09