Trial Condition(s):

Diabetes Mellitus

Influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting (CATERING)

Bayer Identifier:

13928

ClinicalTrials.gov Identifier:

NCT01333774

EudraCT Number:

Not Available

Study Completed

Trial 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.

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)

Trial Summary

Enrollment Goal
423
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 

Trial Design