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

Diabetes Mellitus Clinical Trial

— CATERING  

Official title:

Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333774
• Other study ID #: 13928
• Secondary ID: GB0810PL
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: May 3, 2012
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c value between initial and final visit		approx. 3 mths after acarbose treatment initiation	No
Secondary	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	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.