GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients

NCT01219582

Type 2 Diabetes

COMPLETED

Diabetes Treatment With Glucobay in Combination With Metformin

NCT01612741

Type 2 Diabetes Mellitus

COMPLETED

Diabetes Treatment With Glucobay in Combination With Sulfonylurea

NCT01613105

Type 2 Diabetes Mellitus

COMPLETED

Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

NCT01961388

Diabetes Mellitus

WITHDRAWN

GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

NCT00909051

Diabetes Mellitus

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Acarbose/Metformin (Glucobay M, BAY81-9783)

Intervention Type DRUG

Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acarbose/Metformin (Glucobay M, BAY81-9783)

Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No