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OpenTrials
Completed

NCT Number: NCT01612741

Diabetes Treatment With Glucobay in Combination With Metformin

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose (Precose/Glucobay, BAYG5421)

Drug

Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.

Primary outcomes

  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 outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2012
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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