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Diabetes Treatment With Glucobay in Combination With Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612741
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):

June 4, 2012
June 6, 2012
July 8, 2014
April 2008
January 2009   (Final data collection date for primary outcome measure)
  • Data collection on body weight [ Time Frame: 16 weeks ]
  • Data collection on blood glucose [ Time Frame: 16 weeks ]
  • Data collection on Hba1c [ Time Frame: 16 weeks ]
  • Data collection on pre treatment concomitant diseases [ Time Frame: 16 weeks ]
Same as current
Complete list of historical versions of study NCT01612741 on Archive Site
Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 16 weeks ]
Same as current
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Diabetes Treatment With Glucobay in Combination With Metformin
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
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Type 2 diabetes
Type 2 Diabetes Mellitus
Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.
Group 1
Intervention: Drug: Acarbose (Precose/Glucobay, BAYG5421)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
GB0711IN ( Other Identifier: company internal )
Not Provided
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Study Director: Bayer Study Director Bayer
July 2014