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.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01915264
First received: July 25, 2013
Last updated: April 18, 2014
Last verified: April 2014

July 25, 2013
April 18, 2014
July 2014
September 2015   (final data collection date for primary outcome measure)
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01915264 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Type 2 diabetes

Diabetes Mellitus, Type 2
Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.
Group 1
Intervention: Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10000
September 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
India
 
NCT01915264
16445, GB1310IN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP