Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-12 @ 10:43 AM
Study NCT ID:
NCT01257334
Status:
UNKNOWN
Last Update Posted:
2010-12-09
First Post:
2010-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Sponsor:
Taipei Medical University WanFang Hospital
Organization:
Study Overview
Official Title:
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Status:
UNKNOWN
Status Verified Date:
2010-12
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control.
Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c \> 10%)
Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c \> 10%)
Detailed Description:
Concomitant medications, including other treatments used to treat intercurrent medical conditions during the treatment period, will be recorded on the CRFs. This record will include the name of the medication, frequency, unit dose, dosage, the date when the drug is started and stopped, and the indication for the use of the drug.
Prohibited
The following treatments are prohibited in the trial
1. Other antidiabetic agents except for the background therapy (metformin or the combination of metformin plus sulfonylurea)
2. Treatment with anti-obesity drugs or systemic steroids
3. Other investigational medications
Prohibited
The following treatments are prohibited in the trial
1. Other antidiabetic agents except for the background therapy (metformin or the combination of metformin plus sulfonylurea)
2. Treatment with anti-obesity drugs or systemic steroids
3. Other investigational medications
Study Oversight
Has Oversight DMC:
True
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?: