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NCT00909051 Clinical Trial

GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

Diabetes Mellitus Clinical Trial

Official title:
Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00909051
Other study ID # 14284
Secondary ID GB0701
Status Completed
Phase
First received
Last updated
Start date March 24, 2009
Est. completion date December 31, 2010

Study information
Verified date June 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.

Recruitment information / eligibility
Status Completed
Enrollment 15729
Est. completion date December 31, 2010
Est. primary completion date December 31, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study. Exclusion Criteria: - Exclusion criteria must be read in conjunction with the local product information.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Acarbose (Glucobay, BAYG5421)
Patients with diabetes type 2 newly treated with Glucobay

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Algeria,  Bosnia and Herzegovina,  Cambodia,  China,  Hong Kong,  India,  Indonesia,  Korea, Republic of,  Malaysia,  Moldova, Republic of,  Pakistan,  Philippines,  Russian Federation,  Singapore,  Thailand,  Vietnam, 

References & Publications (1)

Zhang W, Kim D, Philip E, Miyan Z, Barykina I, Schmidt B, Stein H; Gluco VIP study. A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI) During observation period of three months
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