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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT02836704
Brief Summary:
Primary Objective:
-To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs).
Secondary Objective:
* To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) \<7%.
* To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (\<5.6, \<6.1, and \<7.0 mmol/L).
* To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).
* To evaluate the insulin doses change.
* To evaluate the weight change.
* To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence.
* To descriptively evaluate the safety profile.
* To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration).
* Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:
* Age
* Duration of diabetes
* Baseline treatment (OAD)
* Baseline HbA1c, FPG and PP
Detailed Description:
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
Study:
NCT02836704
Study Brief:
Protocol Section:
NCT02836704