Diabetes Treatment With Glucobay in Combination With Metformin

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01612741
First received: June 4, 2012
Last updated: June 24, 2013
Last verified: June 2013
  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 ] [ 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: 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

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

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

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Pharmaceuticals Pvt Ltd
ClinicalTrials.gov Identifier: NCT01612741     History of Changes
Other Study ID Numbers: 13925, GB0711IN
Study First Received: June 4, 2012
Last Updated: June 24, 2013
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
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014