Diabetes Mellitus
Conditions
Keywords
Diabetes, Acarbose, Diet, Compliance, Advising
Brief summary
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.
Interventions
DRUGGlucobay (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
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c value between initial and final visit | approx. 3 mths after acarbose treatment initiation |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events. | approx 3 mths after acarbose treatment initiation |
Countries
Poland
Outcome results
None listed