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

NCT04980027 | Completed Phase 4

• 2 other identifiers: LPS16665U1111-1255-5143
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

  TEAEs including serious adverse events (SAEs) and hypoglycemic episode

  Baseline to Week 24

Secondary Outcomes (11)

• Percentage of participants with at least one confirmed hypoglycemia event

  Baseline to Week 24

• Change in HbA1c from Baseline to week 12 and week 24

  Baseline to Week 12 and Week 24

• Percentage of participants reaching HbA1c target of <7%

  Week 12 and Week 24

• 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

• Change in fasting plasma glucose (FPG) from Baseline to Week 24

  Baseline to Week 24

Study Arms (1)

Insuline Glargine (U300) (Gla-300)

EXPERIMENTAL

Insulin glargine (U300) once daily for 24 weeks on top of non-insulin antidiabetic drug. Insulin dose will be adjusted according to the recommended titration algorithm

Drug: Insulin glargine (U300)

Interventions

Insulin glargine (U300) DRUG

Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous

Also known as: HOE901 Toujeo

Insuline Glargine (U300) (Gla-300)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, α-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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational site Number 3560003

Jaipur, 302017, India

Location

Investigational site Number 3560013

Nashik, 422002, India

Location

Related Publications (1)

• Mohan V, Sethi B, Jain SM, Sahay R, Ramanathan B, Murthy S, Singh KP, Menon S, Gadekar A, Salvi V, Gandhi K. Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naive People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study. Diabetes Ther. 2025 Jul;16(7):1367-1383. doi: 10.1007/s13300-025-01736-5. Epub 2025 May 8.

  PMID: 40338497 DERIVED

Related Links

• LPS16665 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 28, 2021
• Study Start: June 7, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (2)