Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

NCT04075513 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: LPS149472017-002756-91U1111-1197-8171
• Study Type: interventional
• Target: 343
• Locations: 7 countries
• Sites: 7

Brief Summary

Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus. Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring. To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis

  The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12.

  During Week 10 up to Week 12

Secondary Outcomes (11)

• Glucose Total Coefficient of Variation (CV%)

  During Week 10 up to Week 12

• Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis

  During Week 10 up to Week 12

• Glucose Within-day CV% and Between-day CV%

  During Week 10 up to Week 12

• Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12

  Baseline, Week 12

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

  Baseline, Week 12

Study Arms (2)

Toujeo

EXPERIMENTAL

Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

Drug: Insulin glargine, 300 U/ml; Drug: Background therapy: Rapid acting insulin analogs

Tresiba

ACTIVE COMPARATOR

Tresiba (Insulin Degludec, 100U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.

Drug: Insulin degludec, 100U/ml; Drug: Background therapy: Rapid acting insulin analogs

Interventions

Insulin glargine, 300 U/ml DRUG

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

Also known as: Toujeo, HOE901-U300

Toujeo

Insulin degludec, 100U/ml DRUG

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

Also known as: Tresiba

Tresiba

Background therapy: Rapid acting insulin analogs DRUG

Route of administration: SC injection

Toujeo; Tresiba

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with Type 1 Diabetes mellitus.
• Participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year.
• HbA1c greater than or equal to (\>=) 7 percent (%) (53 millimoles per mole \[mmol/mol\]) and less than or equal to (\<=) 10% (86 mmol/mol) at screening.

You may not qualify if:

• Participants not on stable dose of basal insulin analog.
• Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening.
• Participants not having used the same insulins (both basal and rapid) within 30 days prior to screening.
• Participants having received basal insulin dose \>= 0.6 units per kilogram body weight within 30 days prior to screening.
• Participants having received any glucose lowering drugs (including any premixed insulins, human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening.
• End stage renal disease or on renal replacement treatment.
• Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.
• Body weight change \>=5 kilogram within 3 months prior to screening.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

United States

Dallas, Texas, 75000, United States

Location

Investigational site BRAZIL

Brazil, Brazil

Location

Investigational site Germany

Germany, Germany

Location

Investigational site Hungary

Hungary, Hungary

Location

Investigational site Netherlands

Netherlands, Netherlands

Location

Investigational site Turkey

Turkey, Turkey (Türkiye)

Location

Investigational site United Kingdom

United Kingdom, United Kingdom

Location

Related Publications (1)

• Battelino T, Bosnyak Z, Danne T, Mukherjee B, Edelman S, Pilorget V, Choudhary P, Renard E, Bergenstal R. InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther. 2020 Apr;11(4):1017-1027. doi: 10.1007/s13300-020-00781-6. Epub 2020 Feb 25.

  PMID: 32100192 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; insulin degludec

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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: October 9, 2019
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1); GB (1); US (1); DE (1); BR (1); NL (1); HU (1)