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Completed

NCT Number: NCT03406000

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

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.

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Key information

Conditions

Type I Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 076013, Campinas, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INSULIN GLARGINE (U300)

Drug

Pharmaceutical form: Solution for Injection

Route of administration: Subcutaneous injection

Other names: Toujeo, HOE901

Primary outcomes

  1. Mean change in HbA1c

    Time frame: From baseline to Week 24

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

Secondary outcomes

  1. Mean change in HbA1c

    Time frame: From baseline to Week 12

    Mean HbA1c change from baseline to Week 12

  2. Mean change in fasting plasma glucose (FPG)

    Time frame: From baseline to Week 12 and Week 24

    Mean change in FPG from baseline to Week 12 and Week 24

  3. Mean change in fasting SMBG

    Time frame: From baseline to Week 12 and Week 24

    Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24

  4. Mean change in 8-point SMBG

    Time frame: From baseline to Week 12 and Week 24

    Mean change in 8-point SMBG from baseline to Week 12 and Week 24

  5. Proportion of patients achieving HbA1c target of <7.0%

    Time frame: At Weeks 12 and 24

    Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24

  6. Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event

    Time frame: At Weeks 12 and 24

    Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment

  7. Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia

    Time frame: From baseline to Week 24

    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

  8. Proportion of patients with any improvement in HbA1c

    Time frame: From baseline to Week 24

    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

  9. Proportion of patients with no deterioration in HbA1c

    Time frame: From baseline to Week 24

    Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia

  10. Proportion of patients with no deterioration in HbA1c

    Time frame: From baseline to Week 24

    Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia

  11. Adverse events (AEs)

    Time frame: Up to 28 weeks

    Number of adverse events and serious adverse events

  12. Mean change in body weight

    Time frame: From baseline to Week 12 and Week 24

    Mean change in body weight from baseline to Weeks 12 and 24

  13. Mean change in daily insulin doses

    Time frame: From baseline to Week 24

    Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24

  14. Number of patients experiencing hypoglycemia

    Time frame: Up to 28 weeks

  15. Proportion of patients experiencing hypoglycemia

    Time frame: Up to 28 weeks

  16. Number of hypoglycemic events per patient-year

    Time frame: Up to 28 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: TOP1

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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