Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 6:27 AM
Study NCT ID:
NCT02836704
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
-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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1172-2903 | OTHER | UTN | View |