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

NCT01915264 | Withdrawn

• 2 other identifiers: 16445GB1310IN
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Type 2 Diabetes; Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination

Outcome Measures

Primary Outcomes (1)

• Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events

  24 weeks

Secondary Outcomes (10)

• Incidence of adverse events other than hypoglycemia reported

  24 weeks

• Mean change in HbA1c level

  baseline and 24 weeks

• Mean change in fasting blood sugar

  baseline and 24 weeks

• Mean change in postprandial blood sugar

  baseline and 24 weeks

• Mean change in body weight

  baseline and 24 weeks

Study Arms (1)

Group 1

Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)

Interventions

Acarbose/Metformin (Glucobay M, BAY81-9783) DRUG

Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 diabetes

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Acarbose; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 25, 2016

Record last verified: 2016-03