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Diabetes Treatment With Glucobay in Combination With Metformin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612741
First Posted: June 6, 2012
Last Update Posted: July 8, 2014
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.
Information provided by (Responsible Party):
Bayer
  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.

Condition Intervention
Type 2 Diabetes Mellitus Drug: Acarbose (Precose/Glucobay, BAYG5421)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 16 weeks ]

Enrollment: 19509
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612741


Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01612741     History of Changes
Other Study ID Numbers: 13925
GB0711IN ( Other Identifier: company internal )
First Submitted: June 4, 2012
First Posted: June 6, 2012
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Bayer:
Diabetes Mellitus, Type-2
Acarbose
Drug Therapy
Combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action