Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01961388
Status:
WITHDRAWN
Last Update Posted:
2016-06-15
First Post:
2013-10-10
Brief Title:
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARCH AM
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 committeeAll 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 consentPatients will be observed for up to 16 weeks 2 weeksThe 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GB1311IN | OTHER | company internal | None |