Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

Type 2 Diabetes Mellitus Clinical Trial

— SAFEGUARD  

Official title:

Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980027
• Other study ID #: LPS16665
• Secondary ID: U1111-1255-5143
• Status: Completed
• Phase: Phase 4
• Start date: June 7, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)

Description:

The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Participants with Type 2 diabetes mellitus
• Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, a-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening.
• HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.

Exclusion criteria:

• History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.
• Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
• Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use =10 days in relation to hospitalization or an acute illness is accepted).
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine (U300)
Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous

Locations

Country	Name	City	State
India	Investigational site Number 3560003	Jaipur
India	Investigational site Number 3560013	Nasik

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Treatment Emergent Adverse Events (TEAEs)	TEAEs including serious adverse events (SAEs) and hypoglycemic episode	Baseline to Week 24
Secondary	Percentage of participants with at least one confirmed hypoglycemia event		Baseline to Week 24
Secondary	Change in HbA1c from Baseline to week 12 and week 24		Baseline to Week 12 and Week 24
Secondary	Percentage of participants reaching HbA1c target of <7%		Week 12 and Week 24
Secondary	Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)		Week 12 and Week 24
Secondary	Change in fasting plasma glucose (FPG) from Baseline to Week 24		Baseline to Week 24
Secondary	Change in fasting SMBG from Baseline to Week 24		Baseline to Week 24
Secondary	Change in 7-point SMBG profile from Baseline to Week 24		Baseline to Week 24
Secondary	Percentage of participants requiring rescue therapy		Week 12 and Week 24
Secondary	Change in body weight from Baseline to Week 12 and Week 24		Baseline to Week 12 and Week 24
Secondary	Change in insulin dose from Baseline to Week 12 and Week 24		Baseline to Week 12 and Week 24
Secondary	Change in DTSQs scores from Baseline to Week 12 and Week 24	The Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) is measuring patients' satisfaction with their diabetes treatment.Total treatment satisfaction score range from 0 (no satisfaction) to 36 (improvement in treatment satisfaction)	Baseline to Week 12 and Week 24