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Diabetes Treatment With Glucobay in Combination With Sulfonylurea

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01613105
First received: June 4, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  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 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 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 M on Top of Sulfonylurea Under Daily Life Treatment Conditions

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 9400
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (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 upto three times a day with meals or as per investigators descretion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613105

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Pharmaceuticals Pvt Ltd
ClinicalTrials.gov Identifier: NCT01613105     History of Changes
Other Study ID Numbers: 13927, GB0712IN
Study First Received: June 4, 2012
Last Updated: June 26, 2012
Health Authority: India: Ministry of Health

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
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013