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:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT00272012
Brief Summary:
Primary objective:
The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.
Secondary objective:
Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:
* Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
* Change of fasting plasma glucose (baseline to endpoint)
* Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
* Insulin dose (rapid-acting, basal and total daily doses)
* Weight, body-mass index
* Hypoglycemic events
* Adverse events
Study:
NCT00272012
Study Brief:
Protocol Section:
NCT00272012