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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 is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01915264
First received: July 25, 2013
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events other than hypoglycemia reported [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Mean change in HbA1c level [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in fasting blood sugar [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in postprandial blood sugar [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in body weight [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in serum LDL(low‐density lipoprotein) cholesterol [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in serum triglyceride [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in serum HDL (High density lipoproteins) cholesterol [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Number of patient with adverse event (Tolerability) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: October 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 2 diabetes

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:

  • 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 ClinicalTrials.gov identifier: NCT01915264

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
India
Not yet recruiting
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01915264     History of Changes
Other Study ID Numbers: 16445, GB1310IN
Study First Received: July 25, 2013
Last Updated: October 30, 2014
Health Authority: India: Drugs Controller General of India

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Acarbose
Metformin
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014