Phase 4
Completed N=202
Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control
Hypertension · Diabetes Mellitus, Type II
Source: ClinicalTrials.gov NCT01066039 ↗
Enrolled (actual)
202
Serious AEs
3.5%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6 — 6.79; 0.26 Percent HbA1c
Summary
This is a 24-week, prospective, multicenter, open-label, single-arm study to assess the effect of bisoprolol on glycemic level in Type 2 diabetes mellitus (T2DM) controlled subjects with hypertension. The hypothesis of study is that there is no change in glycemic level and lipid metabolism as determined by glycosylated hemoglobin (HbA1c) using bisoprolol in T2DM subjects with suboptimal blood pressure (BP) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6 |
6.79; 0.26 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3 |
0.15 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6 |
147.8; -13.4; 89.0; -9.1; 108.6; -10.5 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6 |
2.3; 0.1; 0.4 | — |
| SECONDARY Change From Baseline in Insulin Level at Months 3 and 6 |
7.5; 0.2; 0.6 | — |
| SECONDARY Change From Baseline in C-Peptide Level at Months 3 and 6 |
2.3; 0.1; 0.2 | — |
| SECONDARY Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6 |
168.6; -0.8; 93.3; -1.6; 49.2; -3.4 | — |
| SECONDARY Change From Baseline in Albumin/Creatinine Ratio at Month 6 |
127.7; 34.3 | — |
| SECONDARY Change From Baseline in Microalbumin Level at Month 6 |
56.6; -3.1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
68; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Age of 20 years or older and less than 80 years
- Subjects with T2DM
- Subjects who have failed to achieve an appropriate BP level as a result of treatment with any antihypertensive drug other than beta blockers - that is, with BP inadequately controlled to greater than or equal to (>=) 130/80 mmHg. However, those who have used a beta blocker before 12 weeks can be enrolled
- Subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to screening
- Signed written informed consent
Exclusion Criteria
- Ongoing insulin therapy
- Change in two HbA1c levels measured at an interval of 4 weeks or longer for the previous 6 months is at least 1% (the last HbA1c is measured within 4 weeks)
- Secondary hypertension
- Subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7 milligram per deciliter)
- Cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick sinus syndrome, second or third degree atrioventricular (AV) block, bradycardia [less than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral infraction attached within 12 weeks)
- Subjects requiring BP control by at least 3 different antihypertensive drugs, or with either systolic blood pressure (SBP) >=180 mmHg or diastolic blood pressure (DBP) >=110 mmHg at baseline
- Subjects with type 1 diabetes mellitus (T1DM)
- Uncontrolled diabetes with HbA1c >9%
- BMI >40 kilogram per square meter (kg/m^2)
- Pulmonary disease (chronic obstructive pulmonary disease [COPD], bronchial asthma)
- Other patients considered by the investigator to be not eligible for participation in this study for a legal or mental reason
- Contraindications for beta-blocker
- Pregnant or lactating women
- Use of an investigational drug within 30 days of entry to the study
Data sourced from ClinicalTrials.gov (NCT01066039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.