Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL

NCT03406000 | Completed Phase 4

• 2 other identifiers: GLARGL08200U1111-1186-2485
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 11

Brief Summary

Primary Objective: To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients. Secondary Objectives:

• To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.
• To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.

Conditions

Type I Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean change in HbA1c

  Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)

  From baseline to Week 24

Secondary Outcomes (16)

• Mean change in HbA1c

  From baseline to Week 12

• Mean change in fasting plasma glucose (FPG)

  From baseline to Week 12 and Week 24

• Mean change in fasting SMBG

  From baseline to Week 12 and Week 24

• Mean change in 8-point SMBG

  From baseline to Week 12 and Week 24

• Proportion of patients achieving HbA1c target of <7.0%

  At Weeks 12 and 24

Study Arms (1)

Insulin glargine (U300)

EXPERIMENTAL

Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.

Drug: INSULIN GLARGINE (U300)

Interventions

INSULIN GLARGINE (U300) DRUG

Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection

Also known as: Toujeo, HOE901

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:

• Male or Female.
• Age ≥ 18 years.
• With Type 1 diabetes mellitus.
• Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.
• Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.
• Patients who have signed an Informed Consent Form.

You may not qualify if:

• Type 2 diabetes mellitus.
• Known hypoglycemia unawareness
• Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.
• End-stage renal failure or being on hemodialysis.
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
• Known hypersensitivity / intolerance to insulin glargine or any of its excipients.
• Patients treated with glucagon like peptide agonists.
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.
• Pregnant or lactating women.
• Women of childbearing potential with no effective contraceptive method.
• Participation in another clinical trial.
• 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 (11)

Investigational Site Number 076013

Campinas, 13092-132, Brazil

Location

Investigational Site Number 076016

Curitiba, 80030-110, Brazil

Location

Investigational Site Number 076007

Curitiba, 80810-140, Brazil

Location

Investigational Site Number 076005

Fortaleza, Brazil

Location

Investigational Site Number 076002

Goiânia, 74175-100, Brazil

Location

Investigational Site Number 076004

Porto Alegre, 91350-250, Brazil

Location

Investigational Site Number 076011

Ribeirão Preto, 14049900, Brazil

Location

Investigational Site Number 076006

São José dos Campos, 12243-280, Brazil

Location

Investigational Site Number 076015

São Paulo, 04022-001, Brazil

Location

Investigational Site Number 076012

São Paulo, 05403-000, Brazil

Location

Investigational Site Number 076001

São Paulo, Brazil

Location

Related Publications (1)

• Dualib PM, Dib SA, Augusto GA, Truzzi AC, de Paula MA, Rea RR. Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes. Diabetol Metab Syndr. 2024 Jul 9;16(1):152. doi: 10.1186/s13098-024-01385-x.

  PMID: 38982528 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: January 15, 2018
• First Posted: January 23, 2018
• Study Start: January 22, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (11)