stop_circleTerminated/Withdrawn

Diabetes Mellitus, Type 2

Bayer Identifier:

16445

ClinicalTrials.gov Identifier:

NCT01915264

EudraCT Number:

Not Available

EU CT Number:

Not Available
GLucobay M – Evaluation Of safety and effectiveness in type 2 diabetes not well controlled on monotherapy in real life practice

Trial purpose

The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Key Participants Requirements

Sex

Both

Age

0 - N/A

  • - Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
    - Willing to give informed consent for participating in this study
  • - Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed & recorded in case record form.
    - Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
    - Exclusion criteria should be read in conjunction with local product information

Trial summary

Enrollment Goal
0
Trial Dates
August 2015 - March 2017
Phase
N/A
Could I Receive a placebo
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many Locations, India

Primary Outcome

  • Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse events other than hypoglycemia reported
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Mean change in HbA1c level
    date_rangeTime Frame:
    baseline and 24 weeks
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    Safety Issue:
    No
  • Mean change in fasting blood sugar
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in postprandial blood sugar
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in body weight
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in serum LDL(low‐density lipoprotein) cholesterol
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in serum triglyceride
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in serum HDL (High density lipoproteins) cholesterol
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale
    date_rangeTime Frame:
    baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patient with adverse event (Tolerability)
    date_rangeTime Frame:
    Baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Glucobay M – Evaluation of safety and effectiveness in type 2 diabetes not well controlled on monotherapy in real life practice
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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