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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 (SAFEGUARD)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Insulin glargine (U300)

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

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.

Sites / Locations

Investigational site Number 3560003
Investigational site Number 3560013

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insuline Glargine (U300) (Gla-300)

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

TEAEs including serious adverse events (SAEs) and hypoglycemic episode

Secondary Outcome Measures

Percentage of participants with at least one confirmed hypoglycemia event

Change in HbA1c from Baseline to week 12 and week 24

Percentage of participants reaching HbA1c target of <7%

Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)

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

Change in fasting SMBG from Baseline to Week 24

Change in 7-point SMBG profile from Baseline to Week 24

Percentage of participants requiring rescue therapy

Change in body weight from Baseline to Week 12 and Week 24

Change in insulin dose from Baseline to Week 12 and Week 24

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)

Full Information

NCT ID

NCT04980027

First Posted

July 19, 2021

Last Updated

January 30, 2023

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04980027

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 7, 2021 (Actual)

Primary Completion Date

December 23, 2022 (Actual)

Study Completion Date

December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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)

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insuline Glargine (U300) (Gla-300)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (U300)

Other Intervention Name(s)

HOE901 Toujeo

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

Description

TEAEs including serious adverse events (SAEs) and hypoglycemic episode

Time Frame

Baseline to Week 24

Secondary Outcome Measure Information:

Title

Percentage of participants with at least one confirmed hypoglycemia event

Time Frame

Baseline to Week 24

Title

Change in HbA1c from Baseline to week 12 and week 24

Time Frame

Baseline to Week 12 and Week 24

Title

Percentage of participants reaching HbA1c target of <7%

Time Frame

Week 12 and Week 24

Title

Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)

Time Frame

Week 12 and Week 24

Title

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

Time Frame

Baseline to Week 24

Title

Change in fasting SMBG from Baseline to Week 24

Time Frame

Baseline to Week 24

Title

Change in 7-point SMBG profile from Baseline to Week 24

Time Frame

Baseline to Week 24

Title

Percentage of participants requiring rescue therapy

Time Frame

Week 12 and Week 24

Title

Change in body weight from Baseline to Week 12 and Week 24

Time Frame

Baseline to Week 12 and Week 24

Title

Change in insulin dose from Baseline to Week 12 and Week 24

Time Frame

Baseline to Week 12 and Week 24

Title

Change in DTSQs scores from Baseline to Week 12 and Week 24

Description

Time Frame

Baseline to Week 12 and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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, 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational site Number 3560003

City

Jaipur

ZIP/Postal Code

302017

Country

India

Facility Name

Investigational site Number 3560013

City

Nasik

ZIP/Postal Code

422002

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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