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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Acarbose/Metformin (Glucobay M, BAY81-9783); Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events other than hypoglycemia reported	24 weeks
Mean change in HbA1c level	baseline and 24 weeks
Mean change in fasting blood sugar	baseline and 24 weeks
Mean change in postprandial blood sugar	baseline and 24 weeks
Mean change in body weight	baseline and 24 weeks
Mean change in serum LDL(low-density lipoprotein) cholesterol	baseline and 24 weeks
Mean change in serum triglyceride	baseline and 24 weeks
Mean change in serum HDL (High density lipoproteins) cholesterol	baseline and 24 weeks
Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale	baseline and 24 weeks
Number of patient with adverse event (Tolerability)	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Type 2 Diabetes; Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: 16445; GB1310IN (Other Identifier: company intermal)