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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Bay G5421 Glucobay; Drug: Metformin

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Acarbose_BAY G5421	Drug: Bay G5421 Glucobay; Oral, dosage of Acarbose as per the directions of treating physician
Group 2; Metformin	Drug: Metformin; Oral, dosage of Metformin as per the directions of treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Mean change of Body weight	baseline and 16 weeks
Mean change of triglyceride(TG)	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of HbA1c	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of FBG	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of LDL	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of HDL	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of TC	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of TG	baseline and 16 weeks
Compare the mean change between acarbose and metformin arm of Body weight	baseline and 16 weeks
Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks	baseline and 16 weeks
Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period	16 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 Diabetes
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: 16667; GB1311IN (Other Identifier: company internal)