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

Type 2 Diabetes Mellitus Clinical Trial

— ARTEMIS-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760991
• Other study ID #: LPS15396
• Secondary ID: U1111-1203-8663
• Status: Completed
• Phase: Phase 4
• Start date: December 18, 2018
• Est. completion date: September 23, 2020

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE (U300)
Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational site Argentina	Buenos Aires
Colombia	investigational site COLOMBIA	Colombia
Egypt	investigational site Egypt	Egypt
Hong Kong	investigational site HONG KONG	Hong Kong
India	investigational site INDIA	India
Indonesia	Investigational site Indonesia	Indonesia
Lebanon	investigational site LEBANON	Lebanon
Malaysia	Investigational site Malaysia	Putrajaya
Peru	Investigational site PERU	Peru
Philippines	investigational site PHILIPPINES	Philippines
Saudi Arabia	Investigational site Saudi Arabia	Saudi Arabia
South Africa	Investigational site South Africa	South Africa
Thailand	Investigational site Thailand	Thailand
Turkey	investigational site TURKEY	Turkey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Colombia,  Egypt,  Hong Kong,  India,  Indonesia,  Lebanon,  Malaysia,  Peru,  Philippines,  Saudi Arabia,  South Africa,  Thailand,  Turkey, 

Outcome

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