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Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)

Primary Purpose

Type I Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
INSULIN GLARGINE (U300)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 076013
  • Investigational Site Number 076016
  • Investigational Site Number 076007
  • Investigational Site Number 076005
  • Investigational Site Number 076002
  • Investigational Site Number 076004
  • Investigational Site Number 076011
  • Investigational Site Number 076006
  • Investigational Site Number 076015
  • Investigational Site Number 076012
  • Investigational Site Number 076001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin glargine (U300)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in HbA1c
Mean HbA1c change from baseline to Week 12
Mean change in fasting plasma glucose (FPG)
Mean change in FPG from baseline to Week 12 and Week 24
Mean change in fasting SMBG
Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24
Mean change in 8-point SMBG
Mean change in 8-point SMBG from baseline to Week 12 and Week 24
Proportion of patients achieving HbA1c target of <7.0%
Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24
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
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
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
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
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
Adverse events (AEs)
Number of adverse events and serious adverse events
Mean change in body weight
Mean change in body weight from baseline to Weeks 12 and 24
Mean change in daily insulin doses
Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
Number of patients experiencing hypoglycemia
Proportion of patients experiencing hypoglycemia
Number of hypoglycemic events per patient-year

Full Information

First Posted
January 15, 2018
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03406000
Brief Title
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin glargine (U300)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE (U300)
Other Intervention Name(s)
Toujeo, HOE901
Intervention Description
Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection
Primary Outcome Measure Information:
Title
Mean change in HbA1c
Description
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)
Time Frame
From baseline to Week 24
Secondary Outcome Measure Information:
Title
Mean change in HbA1c
Description
Mean HbA1c change from baseline to Week 12
Time Frame
From baseline to Week 12
Title
Mean change in fasting plasma glucose (FPG)
Description
Mean change in FPG from baseline to Week 12 and Week 24
Time Frame
From baseline to Week 12 and Week 24
Title
Mean change in fasting SMBG
Description
Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24
Time Frame
From baseline to Week 12 and Week 24
Title
Mean change in 8-point SMBG
Description
Mean change in 8-point SMBG from baseline to Week 12 and Week 24
Time Frame
From baseline to Week 12 and Week 24
Title
Proportion of patients achieving HbA1c target of <7.0%
Description
Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24
Time Frame
At Weeks 12 and 24
Title
Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event
Description
Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment
Time Frame
At Weeks 12 and 24
Title
Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia
Description
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
Time Frame
From baseline to Week 24
Title
Proportion of patients with any improvement in HbA1c
Description
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
Time Frame
From baseline to Week 24
Title
Proportion of patients with no deterioration in HbA1c
Description
Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia
Time Frame
From baseline to Week 24
Title
Proportion of patients with no deterioration in HbA1c
Description
Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia
Time Frame
From baseline to Week 24
Title
Adverse events (AEs)
Description
Number of adverse events and serious adverse events
Time Frame
Up to 28 weeks
Title
Mean change in body weight
Description
Mean change in body weight from baseline to Weeks 12 and 24
Time Frame
From baseline to Week 12 and Week 24
Title
Mean change in daily insulin doses
Description
Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
Time Frame
From baseline to Week 24
Title
Number of patients experiencing hypoglycemia
Time Frame
Up to 28 weeks
Title
Proportion of patients experiencing hypoglycemia
Time Frame
Up to 28 weeks
Title
Number of hypoglycemic events per patient-year
Time Frame
Up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 076013
City
Campinas
ZIP/Postal Code
13092-132
Country
Brazil
Facility Name
Investigational Site Number 076016
City
Curitiba
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Investigational Site Number 076007
City
Curitiba
ZIP/Postal Code
80810-140
Country
Brazil
Facility Name
Investigational Site Number 076005
City
Fortaleza
Country
Brazil
Facility Name
Investigational Site Number 076002
City
Goiânia
ZIP/Postal Code
74175-100
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Porto Alegre
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Investigational Site Number 076011
City
Ribeirão Preto
ZIP/Postal Code
14049900
Country
Brazil
Facility Name
Investigational Site Number 076006
City
São José dos Campos
ZIP/Postal Code
12243-280
Country
Brazil
Facility Name
Investigational Site Number 076015
City
São Paulo
ZIP/Postal Code
04022-001
Country
Brazil
Facility Name
Investigational Site Number 076012
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Investigational Site Number 076001
City
SãO Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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