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

Diabetes Mellitus, Type 2 Clinical Trial

— GLORY  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01915264
• Other study ID #: 16445
• Secondary ID: GB1310IN
• Status: Withdrawn
• Phase: N/A
• First received: July 25, 2013
• Last updated: April 22, 2016
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Acarbose/Metformin (Glucobay M, BAY81-9783)
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events		24 weeks	Yes
Secondary	Incidence of adverse events other than hypoglycemia reported		24 weeks	Yes
Secondary	Mean change in HbA1c level		baseline and 24 weeks	No
Secondary	Mean change in fasting blood sugar		baseline and 24 weeks	No
Secondary	Mean change in postprandial blood sugar		baseline and 24 weeks	No
Secondary	Mean change in body weight		baseline and 24 weeks	No
Secondary	Mean change in serum LDL(low-density lipoprotein) cholesterol		baseline and 24 weeks	No
Secondary	Mean change in serum triglyceride		baseline and 24 weeks	No
Secondary	Mean change in serum HDL (High density lipoproteins) cholesterol		baseline and 24 weeks	No
Secondary	Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale		baseline and 24 weeks	No
Secondary	Number of patient with adverse event (Tolerability)		Baseline and 24 weeks	No

External Links

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