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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.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01333774
First received: April 4, 2011
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: Acarbose
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333774

Locations
Poland
Many Locations, Poland
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 Sp. z o.o., Poland
ClinicalTrials.gov Identifier: NCT01333774     History of Changes
Other Study ID Numbers: 13928, GB0810PL
Study First Received: April 4, 2011
Last Updated: May 3, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Diabetes
Acarbose
Diet
Compliance
Advising

Additional relevant MeSH terms:
Diabetes Mellitus
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 21, 2013