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

Diabetes Mellitus Clinical Trial

— STARCH AM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01961388
• Other study ID #: 16667
• Secondary ID: GB1311IN
• Status: Withdrawn
• Phase: N/A
• First received: October 10, 2013
• Last updated: June 14, 2016
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Bay G5421 Glucobay
Oral, dosage of Acarbose as per the directions of treating physician
• Metformin
Oral, dosage of Metformin as per the directions of treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean change of HbA1c		Baseline and 16 weeks	No
Secondary	Mean change of fasting blood glucose(FBG)		Base line and 16 weeks	No
Secondary	Mean change of low density lipoprotein cholesterol(LDL)		baseline and 16 weeks	No
Secondary	Mean change of high density lipoprotein cholesterol(HDL)		Baseline and 16 weeks	No
Secondary	Mean change of total cholesterol(TC)		baseline and 16 weeks	No
Secondary	Mean change of Body weight		baseline and 16 weeks	No
Secondary	Mean change of triglyceride(TG)		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of HbA1c		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of FBG		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of LDL		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of HDL		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of TC		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of TG		baseline and 16 weeks	No
Secondary	Compare the mean change between acarbose and metformin arm of Body weight		baseline and 16 weeks	No
Secondary	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	Yes
Secondary	Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period		16 weeks	Yes

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