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:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT01630369
Brief Summary:
Primary Objective:
\- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)
Secondary Objectives:
* To evaluate the percentage of patients with Hb A1c \< 7.5%,
* To evaluate the rate of hypoglycaemia (symptomatic, severe)
* To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
* To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
* To assess the overall safety
* To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)
Detailed Description:
6 months
Study:
NCT01630369
Study Brief:
Protocol Section:
NCT01630369