stop_circleTerminated/Withdrawn

Diabetes Mellitus

Bayer Identifier:

16667

ClinicalTrials.gov Identifier:

NCT01961388

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to assess the dietary carbohydrate content of Indian diabetics with special therapeutic view on effectiveness of acarbose and metformin monotherapy

Trial purpose

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included
  • - Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
    - Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered

Trial summary

Enrollment Goal
0
Trial Dates
August 2015 - June 2017
Phase
N/A
Could I Receive a placebo
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many Locations, India

Primary Outcome

  • The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks
    The primary outcome will be summarized separately in acarbose and metformin monotherapy treated patients having carbohydrates consumption (National Institute of Nutrition (NIN), India recommend50% to 60% of total calories from carbohydrates in balance diet : - Below NIN recommendation (< 50%) - As per NIN recommendation (50% to 60%) - Above NIN recommendation (> 60%)
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean change of HbA1c
    date_rangeTime Frame:
    Baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of fasting blood glucose(FBG)
    date_rangeTime Frame:
    Base line and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of low density lipoprotein cholesterol(LDL)
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of high density lipoprotein cholesterol(HDL)
    date_rangeTime Frame:
    Baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of total cholesterol(TC)
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of Body weight
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of triglyceride(TG)
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of HbA1c
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of FBG
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of LDL
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of HDL
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of TC
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of TG
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Compare the mean change between acarbose and metformin arm of Body weight
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks
    date_rangeTime Frame:
    baseline and 16 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Study to assess the dietary carbohydrate content of Indian diabetics with special therapeutic view on effectiveness of acarbose and metformin monotherapy
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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