Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Completed

• Conditions: Diabetes
• Interventions: Drug: Insulin glargine (U300)

• Registration Number: NCT03703869
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

* Assess effectiveness in achieving glycemic goal measured by HbA1c;

* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;

* Assess requirement for intensification of therapy by additional antidiabetics.

* Assess incidence of hypoglycemia;

* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);

* Assess change in body weight.

Detailed Description

Patients will be observed for one year

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Primary Completion: 2019-06-28
• Study Completion: 2020-02-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4589

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin glargine (U300)	Insulin glargine (U300)	Insulin glargine (U300) dosage and dosing time as per local product labeling

Primary Outcome Measures

Name	Time	Method
Change in HbA1c at month 6	Baseline, month 6	Percentage of patients achieving Hemoglobin A1c \<7.0%.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline, months 3, 6, 12	Change from baseline in HbA1c at 3, 6, and 12 months
Change in Self-Monitored Plasma Glucose	Baseline, months 3, 6, 12	Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months
Hypoglycemia	Baseline to month 12	Number of participants with symptomatic hypoglycemic events
Adverse events	Baseline to month 12	Number of participants with Adverse Events
Serious adverse events	Baseline to month 12	Number of participants with Serious Adverse Events
Change in fasting plasma glucose	Baseline, months 3, 6, 12	Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months
Body weight	Baseline to month 12	Change in average body weight

Trial Locations

Locations (388)

Investigational Site Number 1700001; 🇨🇴 Barranquilla, Colombia

Investigational Site Number 1700004; 🇨🇴 Bogota, Colombia

Investigational Site Number 1700010; 🇨🇴 Bogota, Colombia

Investigational Site Number 1700005; 🇨🇴 Cali, Colombia

Investigational Site Number 1700009; 🇨🇴 Cali, Colombia

Investigational Site Number 1700003; 🇨🇴 Ibague, Colombia

Investigational Site Number 1700007; 🇨🇴 Manizales, Colombia

Investigational Site Number 1700006; 🇨🇴 Popayan, Colombia

Investigational Site Number 1700002; 🇨🇴 Zipaquira, Colombia

Investigational Site Number 8180015; 🇪🇬 Alexandria, Egypt

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