Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

NCT01961388 | Withdrawn

• 2 other identifiers: 16667GB1311IN
• 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 effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks

  The primary outcome will be summarized separately in acarbose and metformin monotherapy treated patients having carbohydrates consumption (National Institute of Nutrition (NIN), India recommend50% to 60% of total calories from carbohydrates in balance diet : - Below NIN recommendation (\< 50%) - As per NIN recommendation (50% to 60%) - Above NIN recommendation (\> 60%)

  baseline and 16 weeks

Secondary Outcomes (17)

• Mean change of HbA1c

  Baseline and 16 weeks

• Mean change of fasting blood glucose(FBG)

  Base line and 16 weeks

• Mean change of low density lipoprotein cholesterol(LDL)

  baseline and 16 weeks

• Mean change of high density lipoprotein cholesterol(HDL)

  Baseline and 16 weeks

• Mean change of total cholesterol(TC)

  baseline and 16 weeks

Study Arms (2)

Group 1

Acarbose\_BAY G5421

Drug: Bay G5421 Glucobay

Group 2

Metformin

Drug: Metformin

Interventions

Bay G5421 Glucobay DRUG

Oral, dosage of Acarbose as per the directions of treating physician

Group 1

Metformin DRUG

Oral, dosage of Metformin as per the directions of treating physician

Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Drug-naïve sub-optimally controlled (by diet and physical exercise) type 2 diabetic patients (Female and male patients who are at least 18 years of age) selected from secondary or tertiary referral centers, private hospitals / clinic with good inflow of patients with diabetes

You may qualify if:

• Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included

You may not qualify if:

• Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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: October 10, 2013
• First Posted: October 11, 2013
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 15, 2016

Record last verified: 2016-03