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

Type I Diabetes Mellitus Clinical Trial

— TOP1  

Official title:

A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406000
• Other study ID #: GLARGL08200
• Secondary ID: U1111-1186-2485
• Status: Completed
• Phase: Phase 4
• Start date: January 22, 2018
• Est. completion date: February 4, 2019

Study information

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

Clinical Trial 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.

Description:

The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type I Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE (U300)
Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection

Locations

Country	Name	City	State
Brazil	Investigational Site Number 076013	Campinas
Brazil	Investigational Site Number 076007	Curitiba
Brazil	Investigational Site Number 076016	Curitiba
Brazil	Investigational Site Number 076005	Fortaleza
Brazil	Investigational Site Number 076002	Goiânia
Brazil	Investigational Site Number 076004	Porto Alegre
Brazil	Investigational Site Number 076011	Ribeirão Preto
Brazil	Investigational Site Number 076006	São José dos Campos
Brazil	Investigational Site Number 076001	SãO Paulo
Brazil	Investigational Site Number 076012	São Paulo
Brazil	Investigational Site Number 076015	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c	Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)	From baseline to Week 24
Secondary	Mean change in HbA1c	Mean HbA1c change from baseline to Week 12	From baseline to Week 12
Secondary	Mean change in fasting plasma glucose (FPG)	Mean change in FPG from baseline to Week 12 and Week 24	From baseline to Week 12 and Week 24
Secondary	Mean change in fasting SMBG	Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24	From baseline to Week 12 and Week 24
Secondary	Mean change in 8-point SMBG	Mean change in 8-point SMBG from baseline to Week 12 and Week 24	From baseline to Week 12 and Week 24
Secondary	Proportion of patients achieving HbA1c target of <7.0%	Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24	At Weeks 12 and 24
Secondary	Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event	Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment	At Weeks 12 and 24
Secondary	Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia	Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment	From baseline to Week 24
Secondary	Proportion of patients with any improvement in HbA1c	Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24	From baseline to Week 24
Secondary	Proportion of patients with no deterioration in HbA1c	Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia	From baseline to Week 24
Secondary	Proportion of patients with no deterioration in HbA1c	Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia	From baseline to Week 24
Secondary	Adverse events (AEs)	Number of adverse events and serious adverse events	Up to 28 weeks
Secondary	Mean change in body weight	Mean change in body weight from baseline to Weeks 12 and 24	From baseline to Week 12 and Week 24
Secondary	Mean change in daily insulin doses	Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24	From baseline to Week 24
Secondary	Number of patients experiencing hypoglycemia		Up to 28 weeks
Secondary	Proportion of patients experiencing hypoglycemia		Up to 28 weeks
Secondary	Number of hypoglycemic events per patient-year		Up to 28 weeks