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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04980027
Other study ID # LPS16665
Secondary ID U1111-1255-5143
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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