Clinical trial NCT01915264: GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
Official title: Glucobay M - Evaluation of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Type 2 Diabetes
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Incidence of adverse events other than hypoglycemia reported
timeFrame: 24 weeks
measure: Mean change in HbA1c level
timeFrame: baseline and 24 weeks
measure: Mean change in fasting blood sugar
timeFrame: baseline and 24 weeks
measure: Mean change in postprandial blood sugar
timeFrame: baseline and 24 weeks
measure: Mean change in body weight
timeFrame: baseline and 24 weeks
measure: Mean change in serum LDL(low-density lipoprotein) cholesterol
timeFrame: baseline and 24 weeks
measure: Mean change in serum triglyceride
timeFrame: baseline and 24 weeks
measure: Mean change in serum HDL (High density lipoproteins) cholesterol
timeFrame: baseline and 24 weeks
measure: Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale
timeFrame: baseline and 24 weeks
measure: Number of patient with adverse event (Tolerability)
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: