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| ID | Type | Description | Link |
|---|---|---|---|
| MK0736-007 | |||
| 2008_600 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
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| 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). |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0736 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 12 |
| Change From Baseline in Body Weight at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Study terminated after participants completed a minimum of 24 weeks of the study (i.e., Phase A) due to lack of efficacy. Phase B was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0736 0.5 mg | 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). |
| FG001 | MK-0736 2.0 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Placebo |
| Drug |
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| Comparator: HCTZ | Drug |
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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. |
| 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 | Baseline and Week 24 |
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).
| FG002 | MK-0736 8.0 mg | 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). |
| FG003 | HCTZ 12.5 mg → MK-0736 8.0 mg | 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). |
| FG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0736 0.5 mg | 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). |
| BG001 | MK-0736 2.0 mg | 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). |
| BG002 | MK-0736 8.0 mg | 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). |
| BG003 | HCTZ 12.5 mg → MK-0736 8.0 mg | 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). |
| BG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization) | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 12 |
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| Primary | 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. | Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization) | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 12 |
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| Secondary | 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 | Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization) | Posted | Least Squares Mean | Standard Error | Percentage Change | Baseline and Week 12 |
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| Secondary | 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. | Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization) | Posted | Least Squares Mean | Standard Error | kg | Baseline and Week 24 |
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| Secondary | 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 Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization) | Posted | Least Squares Mean | Standard Error | Percentage Change | Baseline and Week 24 |
|
76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-0736 0.5 mg | 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). | 9 | 137 | 46 | 137 | ||
| EG001 | MK-0736 2.0 mg | 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). | 7 | 134 | 54 | 134 | ||
| EG002 | MK-0736 8.0 mg | 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). | 6 | 141 | 54 | 141 | ||
| EG003 | HCTZ 12.5 mg → MK-0736 8.0 mg | 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). | 0 | 71 | 25 | 71 | ||
| EG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) | 5 | 137 | 43 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Eczema infected | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Paresis cranial nerve | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDevelopment@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Constrained longitudinal data analysis |
Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment |
| 0.919 |
| Difference in least squares means |
| -0.1 |
| 2-Sided |
| 95 |
| -2.1 |
| 1.9 |
| No |
| Superiority or Other |
| Constrained longitudinal data analysis | Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment | 0.829 | Difference in least squares means | -0.2 | 2-Sided | 95 | -2.2 | 1.8 | No | Superiority or Other |
| Constrained longitudinal data analysis | Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment | 0.074 | Difference in least squares means | -2.1 | 2-Sided | 95 | -4.5 | 0.2 | No | Superiority or Other |
| Constrained longitudinal data analysis | Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment | 0.393 | Difference in least squares means | 1.0 | 2-Sided | 95 | -1.3 | 3.3 | No | Superiority or Other |
| Constrained longitudinal data analysis | Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment | 0.088 | Difference in least squares means | 2.0 | 2-Sided | 95 | -0.3 | 4.4 | No | Superiority or Other |
| Constrained longitudinal data analysis | Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment | 0.108 | Difference in least squares means | 1.9 | 2-Sided | 95 | -0.4 | 4.3 | No | Superiority or Other |
| OG003 | HCTZ 12.5 mg → MK-0736 8.0 mg | 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). |
| OG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, 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). |
| OG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) |
|
|
|
| OG003 | HCTZ 12.5 mg → MK-0736 8.0 mg | 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). |
| OG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, 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). |
| OG004 | Placebo | One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) |
|
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