Back to resultsDose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
Primary Purpose
Type 2 Diabetes Mellitus, Hypertension
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0736
Comparator: Placebo
Comparator: HCTZ
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
MK-0736 0.5 mg
MK-0736 2.0 mg
MK-0736 8.0 mg
HCTZ 12.5 mg → MK-0736 8.0 mg
Placebo
Arm Description
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).
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).
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).
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).
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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
Full Information
NCT ID
NCT00806585
First Posted
December 10, 2008
Last Updated
September 18, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00806585
Brief Title
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
620 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-0736 0.5 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
MK-0736 2.0 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
MK-0736 8.0 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
HCTZ 12.5 mg → MK-0736 8.0 mg
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
Intervention Type
Drug
Intervention Name(s)
MK-0736
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Type
Drug
Intervention Name(s)
Comparator: HCTZ
Primary Outcome Measure Information:
Title
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Description
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
Title
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
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
Title
Change From Baseline in Body Weight at Week 24
Description
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
Title
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Description
HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
We'll reach out to this number within 24 hrs