Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diabetes Treatment With Glucobay in Combination With Sulfonylurea

This study has been completed.
Information provided by:
Bayer Identifier:
First received: June 4, 2012
Last updated: June 24, 2013
Last verified: June 2013

June 4, 2012
June 24, 2013
April 2008
December 2008   (final data collection date for primary outcome measure)
  • Data collection on body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Data collection on blood glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Data collection on Hba1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Data collection on pre treatment concomitant diseases [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01613105 on Archive Site
Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Diabetes Treatment With Glucobay in Combination With Sulfonylurea
Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Sulfonylurea 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 sulfonylurea 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 sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance 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.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Type 2 diabetes

Type 2 Diabetes Mellitus
Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 upto 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.
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

  • According to local product information
18 Years and older
Contact information is only displayed when the study is recruiting subjects
13927, GB0712IN
Medical Director, Bayer Pharmaceuticals Pvt Ltd
Not Provided
Study Director: Bayer Study Director Bayer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP