check_circleStudy Completed

Type 2 Diabetes Mellitus

Bayer Identifier:

13925

ClinicalTrials.gov Identifier:

NCT01612741

EudraCT Number:

Not Available

EU CT Number:

Not Available
Diabetes treatment with Glucobay in combination with metformin

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - According to local product information

Trial summary

Enrollment Goal
19509
Trial Dates
April 2008 - January 2009
Phase
N/A
Could I Receive a placebo
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, India

Primary Outcome

  • Data collection on body weight
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Data collection on blood glucose
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Data collection on Hba1c
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Data collection on pre treatment concomitant diseases
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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