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 - GLORY

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/12/004227

Enrollment

10000

Registered

2013-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type-2 Diabetes

Interventions

Intervention1: Acarbose/metformin fixed dose combination : Patient will be enrolled after the decision to administer the combination for type-2 diabetes management has been taken. Total Duration of Th

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse eventsTimepoint: 24 weeks	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDrPravin Manjrekar

Bayer Zydus Pharma

pravin.manjrekar@bayerzyduspharma.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026