Trial · NCT00871871
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
NCT00871871, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2011-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed). Trials, record NCT00871871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00871871
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
- NCT number
- NCT00871871
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 64 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypertension
- Interventions
- Hydrochlorothiazide (HCTZ), Comparator: Placebo to HCTZ, Isosorbide mononitrate (ISMN), Comparator: Placebo to ISMN
- First posted
- 2009-03-30
- Last updated
- 2015-07-28
- Results first posted
- 2011-09-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose \>= 140 and \<= 199 mg/dL during a 75g oral glucose tolerance test at screening. |
| Primary | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. |
| Primary | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG \<100 mg/dL \& 2 hour plasma glucose (PG) \<140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose \>= 140 and \<= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening. |
| Primary | Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. |
| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose \>= 140 and \<= 199 mg/dL during a 75g oral glucose tolerance test at screening. |
| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening. |
| Secondary | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT) | 90 -120 minutes post-dose | Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG \<100 mg/dL \& 2 hour PG \<140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG \>= 140 and \<= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | 90 -120 minutes post-dose | Number of participants with IGT. | ng/minute | LEAST_SQUARES_MEAN |
| PRIMARY | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | 90 -120 minutes post-dose | Number of participants with IFG. | ng/minute | LEAST_SQUARES_MEAN |
| SECONDARY | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | 90 -120 minutes post-dose | Number of participants with IGT. | (mg/kg/minute)/(µIU/mL) | LEAST_SQUARES_MEAN |
| PRIMARY | Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | 90 -120 minutes post-dose | Number of participants with NGT. | ng/minute | LEAST_SQUARES_MEAN |
| PRIMARY | Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | 90 -120 minutes post-dose | Number of participants who took ISMN/placebo. | (mg/kg/minute)/(µIU/mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG) | 90 -120 minutes post-dose | Number of participants with IFG. | (mg/kg/minute)/(µIU/mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT) | 90 -120 minutes post-dose | Number of participants with NGT. | (mg/kg/minute)/(µIU/mL) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | Hydrochlorothiazide (HCTZ) | 3.44 | Standard Deviation 1.03 | ng/minute | |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT) | Hydrochlorothiazide (HCTZ) Placebo | 3.55 | Standard Deviation 1.03 | ng/minute | |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | Hydrochlorothiazide (HCTZ) | 5.60 | Standard Deviation 1.45 | ng/minute | |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG) | Hydrochlorothiazide (HCTZ) Placebo | 4.50 | Standard Deviation 0.95 | ng/minute | |
| Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | Hydrochlorothiazide (HCTZ) | 0.061 | Standard Deviation 0.044 | (mg/kg/minute)/(µIU/mL) | |
| Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT) | Hydrochlorothiazide (HCTZ) Placebo | 0.045 | Standard Deviation 0.041 | (mg/kg/minute)/(µIU/mL) | |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | Hydrochlorothiazide (HCTZ) | 5.54 | Standard Deviation 2.15 | ng/minute | |
| Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT) | Hydrochlorothiazide (HCTZ) Placebo | 5.01 | Standard Deviation 1.63 | ng/minute | |
| Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | Isosorbide Mononitrate (ISMN) | 0.040 | Standard Deviation 0.027 | (mg/kg/minute)/(µIU/mL) | |
| Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state | Isosorbide Mononitrate (ISMN) Placebo | 0.044 | Standard Deviation 0.041 | (mg/kg/minute)/(µIU/mL) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I | STARTED | HCTZ First, Then HCTZ Placebo | 18 | |
| Part I | STARTED | HCTZ Placebo First, Then HCTZ | 18 | |
| Part I | STARTED | ISMN First, Then ISMN Placebo | 0 | |
| Part I | STARTED | ISMN Placebo First, Then ISMN | 0 | |
| Part I | COMPLETED | HCTZ First, Then HCTZ Placebo | 15 | |
| Part I | COMPLETED | HCTZ Placebo First, Then HCTZ | 15 | |
| Part I | COMPLETED | ISMN First, Then ISMN Placebo | 0 | |
| Part I | COMPLETED | ISMN Placebo First, Then ISMN | 0 | |
| Part I | NOT COMPLETED | HCTZ First, Then HCTZ Placebo | 3 | |
| Part I | NOT COMPLETED | HCTZ Placebo First, Then HCTZ | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events288
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | HCTZ | 0 | 36 | |
| other | Abdominal distension | Gastrointestinal disorders | HCTZ Placebo | 1 | 36 | |
| other | Abdominal distension | Gastrointestinal disorders | ISMN | 0 | 28 | |
| other | Abdominal distension | Gastrointestinal disorders | ISMN Placebo | 0 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | HCTZ | 1 | 36 | |
| other | Abdominal pain | Gastrointestinal disorders | HCTZ Placebo | 0 | 36 | |
| other | Abdominal pain | Gastrointestinal disorders | ISMN | 0 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | ISMN Placebo | 1 | 28 | |
| other | Abdominal pain upper | Gastrointestinal disorders | HCTZ | 0 | 36 | |
| other | Abdominal pain upper | Gastrointestinal disorders | HCTZ Placebo | 2 | 36 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HCTZ | ||
| Total, all-cause mortality | HCTZ Placebo | ||
| Total, all-cause mortality | ISMN | ||
| Total, all-cause mortality | ISMN Placebo | ||
| Total, other adverse events | HCTZ | 29 | 36 |
| Total, other adverse events | HCTZ Placebo | 25 | 36 |
| Total, other adverse events | ISMN | 26 | 28 |
| Total, other adverse events | ISMN Placebo | 17 | 28 |
| Total, serious adverse events | HCTZ | 0 | 36 |
| Total, serious adverse events | HCTZ Placebo | 0 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT00871871
GET https://conductscience.org/api/trials/v1/NCT00871871/flow?page=2