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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus
Intervention	Drug: Bay G5421 Glucobay Drug: Metformin
Phase	N/A
Sponsor	Bayer
Responsible Party	Bayer
ClinicalTrials.gov Identifier	NCT01961388
First Received	October 10, 2013
Last Updated	April 1, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 10, 2013
Last Updated Date	April 1, 2014
Start Date	July 2014
Estimated Primary Completion Date	June 2016
Current Primary Outcome Measures	The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks [Time Frame: baseline and 16 weeks] [Designated as safety issue: No]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%)
Current Secondary Outcome Measures	Mean change of HbA1c [Time Frame: Baseline and 16 weeks] [Designated as safety issue: No] Mean change of fasting blood glucose(FBG) [Time Frame: Base line and 16 weeks] [Designated as safety issue: No] Mean change of low density lipoprotein cholesterol(LDL) [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Mean change of high density lipoprotein cholesterol(HDL) [Time Frame: Baseline and 16 weeks] [Designated as safety issue: No] Mean change of total cholesterol(TC) [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Mean change of Body weight [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Mean change of triglyceride(TG) [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG) [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of HbA1c [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of FBG [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of LDL [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of HDL [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of TC [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of TG [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Compare the mean change between acarbose and metformin arm of Body weight [Time Frame: baseline and 16 weeks] [Designated as safety issue: No] Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks [Time Frame: baseline and 16 weeks] [Designated as safety issue: Yes] Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period [Time Frame: 16 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Official Title	Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
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.
Detailed Description	Not Provided
Study Type	Observational
Study Phase	N/A
Study Design	Observational Model: Cohort, Time Perspective: Prospective
Condition	Diabetes Mellitus
Intervention	Drug: Bay G5421 Glucobay Oral, dosage of Acarbose as per the directions of treating physician Drug: Metformin Oral, dosage of Metformin as per the directions of treating physician
Study Arm (s)	Group 1 Acarbose_BAY G5421 Group 2 Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	12250
Estimated Completion Date	June 2016
Estimated Primary Completion Date	January 2016
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT01961388
Other Study ID Numbers	16667
Has Data Monitoring Committee	No
Information Provided By	Bayer
Study Sponsor	Bayer
Collaborators	Not Provided
Investigators	Study Director: Bayer Study Director Bayer
Verification Date	April 2014

Locations[ + expand ][ + ]