Trial · NCT00744237
Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
NCT00744237, Phase 4, Completed, Forest Laboratories; results first posted 2011-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients. Trials, record NCT00744237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00744237
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
- NCT number
- NCT00744237
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 231 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Interventions
- Nebivolol, Metoprolol ER, HCTZ
- First posted
- 2008-08-29
- Last updated
- 2011-07-29
- Results first posted
- 2011-07-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | visit 5(week 0) and visit 14(week 26) | Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward. |
| Secondary | Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | [visit 5(week 0) and visit 14(week 26)] | Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | visit 5(week 0) and visit 14(week 26) | Percentage | MEAN | |
| SECONDARY | Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | [visit 5(week 0) and visit 14(week 26)] | Unit on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | Nebivolol | 0.12 | Standard Deviation 0.78 | Percentage | |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | Metoprolol ER | 0.00 | Standard Deviation 0.65 | Percentage | |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | Hydrochlorothiazide (HCTZ) | 0.40 | Standard Deviation 0.96 | Percentage | |
| Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Nebivolol | 0.011 | Standard Deviation 9.828 | Unit on a scale | |
| Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Metoprolol ER | 1.156 | Standard Deviation 9.628 | Unit on a scale | |
| Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Hydrochlorothiazide (HCTZ) | -0.662 | Standard Deviation 10.178 | Unit on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebivolol | 83 | |
| Overall Study | STARTED | Metoprolol ER | 73 | |
| Overall Study | STARTED | Hydrochlorothiazide (HCTZ) | 74 | |
| Overall Study | COMPLETED | Nebivolol | 56 | |
| Overall Study | COMPLETED | Metoprolol ER | 46 | |
| Overall Study | COMPLETED | Hydrochlorothiazide (HCTZ) | 59 | |
| Overall Study | NOT COMPLETED | Nebivolol | 27 | |
| Overall Study | NOT COMPLETED | Metoprolol ER | 27 | |
| Overall Study | NOT COMPLETED | Hydrochlorothiazide (HCTZ) | 15 |
Source ClinicalTrials.gov
Adverse events60
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 | Bradycardia | Cardiac disorders | Nebivolol | 6 | 83 | |
| other | Bradycardia | Cardiac disorders | Metoprolol ER | 8 | 73 | |
| other | Bradycardia | Cardiac disorders | Hydrochlorothiazide (HCTZ) | 0 | 74 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Nebivolol | 3 | 83 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Metoprolol ER | 6 | 73 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Hydrochlorothiazide (HCTZ) | 1 | 74 | |
| other | Dizziness | Nervous system disorders | Nebivolol | 5 | 83 | |
| other | Dizziness | Nervous system disorders | Metoprolol ER | 3 | 73 | |
| other | Dizziness | Nervous system disorders | Hydrochlorothiazide (HCTZ) | 3 | 74 | |
| other | Fatigue | General disorders | Nebivolol | 3 | 83 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebivolol | ||
| Total, all-cause mortality | Metoprolol ER | ||
| Total, all-cause mortality | Hydrochlorothiazide (HCTZ) | ||
| Total, other adverse events | Nebivolol | 19 | 83 |
| Total, other adverse events | Metoprolol ER | 17 | 73 |
| Total, other adverse events | Hydrochlorothiazide (HCTZ) | 17 | 74 |
| Total, serious adverse events | Nebivolol | 2 | 83 |
| Total, serious adverse events | Metoprolol ER | 3 | 73 |
| Total, serious adverse events | Hydrochlorothiazide (HCTZ) | 2 | 74 |
Source ClinicalTrials.gov
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.
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/NCT00744237
GET https://conductscience.org/api/trials/v1/NCT00744237/events?page=2