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Diabetes Treatment With Glucobay in Combination With Sulfonylurea

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ClinicalTrials.gov Identifier: NCT01613105
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : June 26, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

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

Study Design

Study Type : Observational
Actual Enrollment : 4564 participants
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 Sulfonylurea Under Daily Life Treatment Conditions
Study Start Date : April 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.


Outcome Measures

Primary Outcome Measures :
  1. Data collection on body weight [ Time Frame: 16 weeks ]
  2. Data collection on blood glucose [ Time Frame: 16 weeks ]
  3. Data collection on Hba1c [ Time Frame: 16 weeks ]
  4. Data collection on pre treatment concomitant diseases [ Time Frame: 16 weeks ]

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

Eligibility Criteria

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) 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
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): NCT01613105


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

Additional Information:
Responsible Party: Medical Director, Bayer Pharmaceuticals Pvt Ltd
ClinicalTrials.gov Identifier: NCT01613105     History of Changes
Other Study ID Numbers: 13927
GB0712IN ( Other Identifier: company internal )
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

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
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs