Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT01257334
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%)
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
Study:
NCT01257334
Study Brief:
Protocol Section:
NCT01257334