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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Bayer Identifier:
First received: July 25, 2013
Last updated: April 22, 2016
Last verified: March 2016
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.

Condition Intervention
Diabetes Mellitus, Type 2
Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glucobay M - Evaluation of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events [ Time Frame: 24 weeks ]

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

Enrollment: 0
Study Start Date: August 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01915264

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01915264     History of Changes
Other Study ID Numbers: 16445
GB1310IN ( Other Identifier: company intermal )
Study First Received: July 25, 2013
Last Updated: April 22, 2016

Keywords provided by Bayer:
Diabetes Mellitus
Type 2 Diabetes
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017