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

NCT03760991 | Completed Phase 4

• 2 other identifiers: LPS15396U1111-1203-8663
• Study Type: interventional
• Target: 372
• Locations: 14 countries
• Sites: 14

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in glycated hemoglobin (HbA1c)

  Absolute change in HbA1c

  Baseline to Week 26

Secondary Outcomes (11)

• Change in glycated hemoglobin (HbA1c)

  Baseline to Week 12

• 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)

  Week 12 and 26

• Change in fasting SMPG

  Baseline to Week 26

• Change in SMPG profile

  Baseline to Week 26

Study Arms (1)

Insulin glargine (U300)

EXPERIMENTAL

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)

Interventions

INSULIN GLARGINE (U300) DRUG

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

Also known as: HOE901, Toujeo, Gla-300

Insulin glargine (U300)

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (14)

Investigational site Argentina

Buenos Aires, Argentina

Location

investigational site COLOMBIA

Colombia, Colombia

Location

investigational site Egypt

Egypt, Egypt

Location

investigational site HONG KONG

Hong Kong, Hong Kong

Location

investigational site INDIA

India, India

Location

Investigational site Indonesia

Indonesia, Indonesia

Location

investigational site LEBANON

Lebanon, Lebanon

Location

Investigational site Malaysia

Putrajaya, Malaysia

Location

Investigational site PERU

Hacienda Perú, Peru

Location

investigational site PHILIPPINES

Philippines, Philippines

Location

Investigational site Saudi Arabia

Saudi Arabia, Saudi Arabia

Location

Investigational site South Africa

South Africa, South Africa

Location

Investigational site Thailand

Thailand, Thailand

Location

investigational site TURKEY

Turkey, Turkey (Türkiye)

Location

Related Publications (1)

• Sethi B, Al-Rubeaan K, Unubol M, Mabunay MA, Berthou B, Pilorget V, Vethakkan SR, Frechtel G. Efficacy and Safety of Insulin Glargine 300 U/mL in People with Type 2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study. Diabetes Ther. 2022 Jul;13(7):1395-1408. doi: 10.1007/s13300-022-01271-7. Epub 2022 Jun 17.

  PMID: 35713873 DERIVED

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: November 29, 2018
• First Posted: December 3, 2018
• Study Start: December 18, 2018
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PH (1); TH (1); ZA (1); TU (1); CO (1); MY (1); IN (1); SA (1); ID (1); HK (1); LE (1); EG (1); AR (1); PE (1)