Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin (ARTEMIS-DM)

April 21, 2022 updated by: Sanofi

A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on Basal Insulin

Primary Objective:

To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300.

Secondary Objectives:

To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes.

To evaluate the safety of Gla-300.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.

Study Type

Interventional

Enrollment (Actual)

372

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • investigational site Argentina
  • Colombia
      • Colombia, Colombia
        • Investigational site Colombia
  • Egypt
      • Egypt, Egypt
        • investigational site Egypt
  • Hong Kong
      • Hong Kong, Hong Kong
        • investigational site HONG KONG
  • India
      • India, India
        • investigational site INDIA
  • Indonesia
      • Indonesia, Indonesia
        • Investigational site Indonesia
  • Lebanon
      • Lebanon, Lebanon
        • investigational site LEBANON
  • Malaysia
      • Putrajaya, Malaysia
        • Investigational site Malaysia
  • Peru
      • Peru, Peru
        • Investigational site PERU
  • Philippines
      • Philippines, Philippines
        • investigational site PHILIPPINES
  • Saudi Arabia
      • Saudi Arabia, Saudi Arabia
        • Investigational site Saudi Arabia
  • South Africa
      • South Africa, South Africa
        • Investigational site South Africa
  • Thailand
      • Thailand, Thailand
        • Investigational site Thailand
  • Turkey
      • Turkey, Turkey
        • Investigational site Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • Participants with type 2 diabetes mellitus.
  • Participants on "standard of care" basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin.
  • Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
  • Fasting plasma glucose values above 130 mg/dL.

Exclusion criteria:

  • Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses [variation more than ±20%]).
  • Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, 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).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin glargine (U300)
Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin
Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: Solution for injection in a prefilled pen

Route of administration: Subcutaneous

Other Names:
  • HOE901, Toujeo, Gla-300

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin (HbA1c)
Time Frame: Baseline to Week 26
Absolute change in HbA1c
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated hemoglobin (HbA1c)
Time Frame: Baseline to Week 12
Absolute change in HbA1c
Baseline to Week 12
Participants with HbA1c below 7%
Time Frame: Week 12 and 26
Percentage of participants with HbA1c below 7%
Week 12 and 26
Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
Time Frame: Week 12 and 26
Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
Week 12 and 26
Change in fasting SMPG
Time Frame: Baseline to Week 26
Absolute change in fasting SMPG
Baseline to Week 26
Change in SMPG profile
Time Frame: Baseline to Week 26
Absolute change in SMPG profile
Baseline to Week 26
Change in fasting plasma glucose (FPG)
Time Frame: Baseline to Week 26
Absolute change in FPG
Baseline to Week 26
Percentage of participants requiring rescue therapy
Time Frame: Baseline to Week 12 and 26
Percentage of participants requiring rescue therapy by additional antidiabetic medication
Baseline to Week 12 and 26
Number of participants with hypoglycemia events
Time Frame: Baseline to Week 26
Number of participants with at least 1 hypoglycemia event
Baseline to Week 26
Number of participants with adverse events (AEs)
Time Frame: Baseline to Week 27
Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness).
Baseline to Week 27
Change in Treatment satisfaction
Time Frame: Baseline to Week 26
Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire
Baseline to Week 26
Number of participants with health care utilization
Time Frame: Baseline to Week 26
Number of participants with health care utilization, including hospitalization, emergency room visits, and office [or specialty] visits
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Actual)

September 23, 2020

Study Completion (Actual)

September 23, 2020

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS15396
  • U1111-1203-8663 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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