Diabetes Treatment With Glucobay in Combination With Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Metformin Under Daily Life Treatment Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612741
• Other study ID #: 13925
• Secondary ID: GB0711IN
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: July 7, 2014
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19509
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.

• In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

• According to local product information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection on body weight		16 weeks	No
Primary	Data collection on blood glucose		16 weeks	No
Primary	Data collection on Hba1c		16 weeks	No
Primary	Data collection on pre treatment concomitant diseases		16 weeks	No
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collection		16 weeks	Yes

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