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Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting (CATERING)

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 4, 2011
Last updated: May 3, 2012
Last verified: May 2012
It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.

Condition Intervention
Diabetes Mellitus Drug: Glucobay (Acarbose, BAYG5421)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in HbA1c value between initial and final visit [ Time Frame: approx. 3 mths after acarbose treatment initiation ]

Secondary Outcome Measures:
  • Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events. [ Time Frame: approx 3 mths after acarbose treatment initiation ]

Enrollment: 423
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Glucobay (Acarbose, BAYG5421)
Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment


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
Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.

Inclusion Criteria:

  • type 2 diabetes
  • age>18 years

Exclusion Criteria:

  • Hypersensitivity to acarbose or any of the excipients
  • age<18
  • pregnancy and in nursing
  • inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
  • chronic intestinal diseases associated with marked disorders of digestion or absorption
  • states which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach] and larger hernias)
  • hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01333774

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

Additional Information:
Responsible Party: Medical Director, Bayer Sp. z o.o., Poland Identifier: NCT01333774     History of Changes
Other Study ID Numbers: 13928
GB0810PL ( Other Identifier: Company internal )
Study First Received: April 4, 2011
Last Updated: May 3, 2012

Keywords provided by Bayer:

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017