Trial Condition(s):
Type 2 Diabetes Mellitus
Diabetes treatment with Glucobay in combination with metformin
Bayer Identifier:
13925
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Data collection on body weightTimeframe: 16 weeks
- Data collection on blood glucoseTimeframe: 16 weeks
- Data collection on Hba1cTimeframe: 16 weeks
- Data collection on pre treatment concomitant diseasesTimeframe: 16 weeks
Secondary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: 16 weeks
Additional Information
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