Trial · NCT01066039
Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control
NCT01066039, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control. Trials, record NCT01066039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01066039
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control
- NCT number
- NCT01066039
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 202 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypertension, Diabetes Mellitus, Type II
- Interventions
- Bisoprolol
- First posted
- 2010-02-10
- Last updated
- 2014-07-04
- Results first posted
- 2014-07-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6 | Baseline, Month 6 | HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3 | Baseline, Month 3 | HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Baseline, Month 6 | The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus \[{SBP minus DBP} divided by 3\]). |
| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6 | Baseline, Months 3 and 6 | HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI \[micro international units per milliliter {mcIU/mL}\] \* FPG \[millimole per liter {mmol/L}\]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline. |
| Secondary | Change From Baseline in Insulin Level at Months 3 and 6 | Baseline, Months 3 and 6 | The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline. |
| Secondary | Change From Baseline in C-Peptide Level at Months 3 and 6 | Baseline, Months 3 and 6 | The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline. |
| Secondary | Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6 | Baseline, Month 6 | The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively. |
| Secondary | Change From Baseline in Albumin/Creatinine Ratio at Month 6 | Baseline, Month 6 | The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline. |
| Secondary | Change From Baseline in Microalbumin Level at Month 6 | Baseline, Month 6 | The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Month 6 | An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. |
Source ClinicalTrials.gov
Outcomes10
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 Glycosylated Hemoglobin (HbA1c) at Month 6 | Baseline, Month 6 | Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured. | Percent HbA1c | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3 | Baseline, Month 3 | FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured. | Percent HbA1c | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Baseline, Month 6 | FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6 | Baseline, Months 3 and 6 | FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured. | mcIU/mL * mmol/L | MEAN |
| SECONDARY | Change From Baseline in Insulin Level at Months 3 and 6 | Baseline, Months 3 and 6 | FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. | mcIU/mL | MEAN |
| SECONDARY | Change From Baseline in C-Peptide Level at Months 3 and 6 | Baseline, Months 3 and 6 | FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6 | Baseline, Month 6 | FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Albumin/Creatinine Ratio at Month 6 | Baseline, Month 6 | FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | ratio | MEAN |
| SECONDARY | Change From Baseline in Microalbumin Level at Month 6 | Baseline, Month 6 | FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category. | mg/dL | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Month 6 | Safety population included all participants who received at least one dose of investigational product. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
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 Glycosylated Hemoglobin (HbA1c) at Month 6 | Bisoprolol | Baseline | 6.79 | Standard Deviation 0.66 | Percent HbA1c |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6 | Bisoprolol | Change at Month 6 | 0.26 | Standard Deviation 0.64 | Percent HbA1c |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3 | Bisoprolol | 0.15 | Standard Deviation 0.51 | Percent HbA1c | |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | SBP: Baseline | 147.8 | Standard Deviation 11.5 | mmHg |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | SBP: Change at Month 6 | -13.4 | Standard Deviation 15.4 | mmHg |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | DBP: Baseline | 89.0 | Standard Deviation 7.3 | mmHg |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | DBP: Change at Month 6 | -9.1 | Standard Deviation 9.0 | mmHg |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | Mean BP: Baseline | 108.6 | Standard Deviation 6.9 | mmHg |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 | Bisoprolol | Mean BP: Change at Month 6 | -10.5 | Standard Deviation 10.2 | mmHg |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6 | Bisoprolol | Baseline | 2.3 | Standard Deviation 1.8 | mcIU/mL * mmol/L |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bisoprolol | 202 | |
| Overall Study | Treated | Bisoprolol | 200 | |
| Overall Study | COMPLETED | Bisoprolol | 158 | |
| Overall Study | NOT COMPLETED | Bisoprolol | 44 |
Source ClinicalTrials.gov
Adverse events83
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 | Oedema | General disorders | Bisoprolol | 1 | 200 | |
| other | Oedema periorbital | General disorders | Bisoprolol | 1 | 200 | |
| other | Pain legs | General disorders | Bisoprolol | 1 | 200 | |
| other | Sensation of warmth | General disorders | Bisoprolol | 1 | 200 | |
| other | Weakness generalized | General disorders | Bisoprolol | 3 | 200 | |
| other | ECG abnormal | Cardiac disorders | Bisoprolol | 1 | 200 | |
| other | AV block first degree | Cardiac disorders | Bisoprolol | 1 | 200 | |
| other | Bradyarrhythmia | Cardiac disorders | Bisoprolol | 1 | 200 | |
| other | Palpitation | Cardiac disorders | Bisoprolol | 1 | 200 | |
| other | Dizziness | Nervous system disorders | Bisoprolol | 6 | 200 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bisoprolol | ||
| Total, other adverse events | Bisoprolol | 61 | 200 |
| Total, serious adverse events | Bisoprolol | 7 | 200 |
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/NCT01066039
GET https://conductscience.org/api/trials/v1/NCT01066039/results?page=2