Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control

NCT01066039 | Completed Phase 4 Results

• 1 other identifier: EMR 200006-509
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Diabetes Mellitus, Type II

Keywords

Bisoprolol; Hypertension; Diabetes mellitus, Type II; Blood pressure; Glycemic level

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.

  Baseline, Month 6

Secondary Outcomes (9)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3

  Baseline, Month 3

• Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6

  Baseline, Month 6

• Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6

  Baseline, Months 3 and 6

• Change From Baseline in Insulin Level at Months 3 and 6

  Baseline, Months 3 and 6

• Change From Baseline in C-Peptide Level at Months 3 and 6

  Baseline, Months 3 and 6

Study Arms (1)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Interventions

Bisoprolol DRUG

Bisoprolol tablet will be administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure is not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose will be adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose will be reduced to 2.5 mg.

Also known as: Concor, Concor Plus, ConcorCor, Lodoz

Bisoprolol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd.: collaborator

Study Sites (1)

Seoul St. Mary´s Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-06

Locations

KR (1)