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Trial · NCT00806585

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

NCT00806585, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2013-12-11

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ConductScience Library. Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007). Trials, record NCT00806585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00806585

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
NCT number
NCT00806585
Status
Terminated
Phases
Phase 2
Enrollment
620 participants, actual
Lead sponsor
Merck Sharp & Dohme LLC
Conditions
Type 2 Diabetes Mellitus, Hypertension
Interventions
MK-0736, Comparator: Placebo, Comparator: HCTZ
First posted
2008-12-11
Last updated
2015-09-21
Results first posted
2013-12-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12Baseline 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.
PrimaryChange From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12Baseline 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.
SecondaryPercent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12Baseline and Week 12LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration
SecondaryChange From Baseline in Body Weight at Week 24Baseline 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.
SecondaryChange From Baseline in Hemoglobin A1c (HbA1c) at Week 24Baseline and Week 24HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12Baseline and Week 12Full 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)mmHgLEAST_SQUARES_MEAN
PRIMARYChange From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12Baseline and Week 12Full 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)mmHgLEAST_SQUARES_MEAN
SECONDARYPercent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12Baseline and Week 12Full 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)Percentage ChangeLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Body Weight at Week 24Baseline and Week 24Full 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)kgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Hemoglobin A1c (HbA1c) at Week 24Baseline and Week 24Full 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)Percentage ChangeLEAST_SQUARES_MEAN

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12MK-0736 0.5 mg-5.8Standard Error 0.7mmHg
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12MK-0736 2.0 mg-5.7Standard Error 0.7mmHg
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12MK-0736 8.0 mg-6.7Standard Error 0.7mmHg
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12HCTZ 12.5 mg → MK-0736 8.0 mg-7.7Standard Error 1.0mmHg
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12Placebo-5.6Standard Error 0.7mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12MK-0736 0.5 mg-5.7Standard Error 1.1mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12MK-0736 2.0 mg-7.2Standard Error 1.1mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12MK-0736 8.0 mg-6.3Standard Error 1.1mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12HCTZ 12.5 mg → MK-0736 8.0 mg-12.4Standard Error 1.5mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12Placebo-5.4Standard Error 1.2mmHg

Participant flow15

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMK-0736 0.5 mg137
Overall StudySTARTEDMK-0736 2.0 mg134
Overall StudySTARTEDMK-0736 8.0 mg141
Overall StudySTARTEDHCTZ 12.5 mg → MK-0736 8.0 mg71
Overall StudySTARTEDPlacebo137
Overall StudyCOMPLETEDMK-0736 0.5 mg105
Overall StudyCOMPLETEDMK-0736 2.0 mg103
Overall StudyCOMPLETEDMK-0736 8.0 mg109
Overall StudyCOMPLETEDHCTZ 12.5 mg → MK-0736 8.0 mg56
Overall StudyCOMPLETEDPlacebo106

Adverse events170

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherOedema peripheralGeneral disordersMK-0736 0.5 mg11371
otherOedema peripheralGeneral disordersMK-0736 2.0 mg21342
otherOedema peripheralGeneral disordersMK-0736 8.0 mg814110
otherOedema peripheralGeneral disordersHCTZ 12.5 mg → MK-0736 8.0 mg2712
otherOedema peripheralGeneral disordersPlacebo21372
otherNasopharyngitisInfections and infestationsMK-0736 0.5 mg21372
otherNasopharyngitisInfections and infestationsMK-0736 2.0 mg81349
otherNasopharyngitisInfections and infestationsMK-0736 8.0 mg31414
otherNasopharyngitisInfections and infestationsHCTZ 12.5 mg → MK-0736 8.0 mg2712
otherNasopharyngitisInfections and infestationsPlacebo51375

Adverse event totals15

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMK-0736 0.5 mg
Total, all-cause mortalityMK-0736 2.0 mg
Total, all-cause mortalityMK-0736 8.0 mg
Total, all-cause mortalityHCTZ 12.5 mg → MK-0736 8.0 mg
Total, all-cause mortalityPlacebo
Total, other adverse eventsMK-0736 0.5 mg46137
Total, other adverse eventsMK-0736 2.0 mg54134
Total, other adverse eventsMK-0736 8.0 mg54141
Total, other adverse eventsHCTZ 12.5 mg → MK-0736 8.0 mg2571
Total, other adverse eventsPlacebo43137

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00806585

GET https://conductscience.org/api/trials/v1/NCT00806585/results?page=2