Clinical trial NCT03760991: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: Baseline to Week 12
measure: Participants with HbA1c below 7%
timeFrame: Week 12 and 26
measure: Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
timeFrame: Week 12 and 26
measure: Change in fasting SMPG
timeFrame: Baseline to Week 26
measure: Change in SMPG profile
timeFrame: Baseline to Week 26
measure: Change in fasting plasma glucose (FPG)
timeFrame: Baseline to Week 26
measure: Percentage of participants requiring rescue therapy
timeFrame: Baseline to Week 12 and 26
measure: Number of participants with hypoglycemia events
timeFrame: Baseline to Week 26
measure: Number of participants with adverse events (AEs)
timeFrame: Baseline to Week 27
measure: Change in Treatment satisfaction
timeFrame: Baseline to Week 26
measure: Number of participants with health care utilization
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Investigational site Argentina
city: Colombia
country: Colombia
facility: investigational site COLOMBIA
city: Egypt
country: Egypt
facility: investigational site Egypt
city: Hong Kong
country: Hong Kong
facility: investigational site HONG KONG
city: India
country: India
facility: investigational site INDIA
city: Indonesia
country: Indonesia
facility: Investigational site Indonesia
city: Lebanon
country: Lebanon
facility: investigational site LEBANON
city: Putrajaya
country: Malaysia
facility: Investigational site Malaysia
city: Peru
country: Peru
facility: Investigational site PERU
city: Philippines
country: Philippines
facility: investigational site PHILIPPINES
city: Saudi Arabia
country: Saudi Arabia
facility: Investigational site Saudi Arabia
city: South Africa
country: South Africa
facility: Investigational site South Africa
city: Thailand
country: Thailand
facility: Investigational site Thailand
city: Turkey
country: Turkey
facility: investigational site TURKEY
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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 Jun 17:1-14. doi: 10.1007/s13300-022-01271-7. Online ahead of print.
citation: 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.