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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT01204593
Brief Summary:
Primary Objective:
To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).
Secondary Objectives:
To evaluate:
* The change of hemoglobin A1c (HbA1c) from baseline to week 12
* The percentage of patients with HbA1c \< 7% at week 12 and week 24
* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
* The incidence of symptomatic hypoglycemias
* Adverse events
Detailed Description:
After a two-week run-in period patients will enter a six-month treatment period.
Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
Study:
NCT01204593
Study Brief:
Protocol Section:
NCT01204593