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A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02688933
First Posted: February 23, 2016
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

To demonstrate that morning injection of Toujeo compared to Lantus will provide better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult patients with type 1 diabetes mellitus.

Secondary Objective:

To demonstrate that treatment with Toujeo compared to Lantus will provide:

  • Lower incidence rate of nocturnal symptomatic hypoglycemia;
  • Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
  • Less variability in CGM profile.

Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: Insulin glargine (U300) HOE901 Drug: Insulin glargine HOE901 Drug: Insulin glulisine HMR1964 Drug: Insulin aspart Drug: Insulin lispro Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of time of glucose concentration within the target range of 70-180 mg/dL (3.9-10 mmol/L) obtained from CGM during the last week(s) of treatment [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Incidence rate of nocturnal symptomatic hypoglycemia, which is defined as symptomatic hypoglycemia as per the ADA classification that occurs between 00:00 and 05.59 hours [ Time Frame: 16 weeks ]
  • Percentage of time glucose concentrations within the target range of 70-140 mg/dL (3.9-7.8 mmol/L) during the last 4 hours of CGM data collection before the next injection of Toujeo or Lantus [ Time Frame: 16 weeks ]
  • Variability of glucose values from CGM, on a daily basis and across days [ Time Frame: 16 weeks ]

Enrollment: 638
Actual Study Start Date: May 5, 2016
Study Completion Date: June 19, 2017
Primary Completion Date: June 19, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toujeo

Toujeo (Insulin Glargine 300 Units/mL) will be self-administered thru subcutaneous (SC) injection once daily in the morning (between waking up and breakfast).

Patients will continue their existing mealtime insulin, which will be injected SC

Drug: Insulin glargine (U300) HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Toujeo
Drug: Insulin glulisine HMR1964
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Apidra
Drug: Insulin aspart
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Novolog
Drug: Insulin lispro
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Humalog
Active Comparator: Lantus

Lantus (Insulin Glargine 100 Units/mL)will be self-administered thru SC injection once daily in the morning (between waking up and breakfast).

Patients will continue their existing mealtime insulin, which will be injected SC

Drug: Insulin glargine HOE901
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Lantus
Drug: Insulin glulisine HMR1964
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Apidra
Drug: Insulin aspart
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Novolog
Drug: Insulin lispro
Pharmaceutical form:Solution Route of administration: subcutaneous
Other Name: Humalog

Detailed Description:
The maximum study duration per patient will be approximately 20 weeks that will consist of a 4-week screening and training period including a 1-2 week CGM performance (allow for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin, a 1-2 week blinded CGM collection with fixed dose of Toujeo and Lantus, and a 2 day post treatment follow-up period.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients (male and female) with type 1 diabetes mellitus (T1DM).
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years or >70 years.
  • Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
  • Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
  • Patients who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association [ADA] classification) during the past month prior to screening.
  • Patients who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
  • Patients receiving less than 1 year treatment with basal plus mealtime insulin.
  • Using any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
  • Requiring >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
  • Using fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
  • Using human regular insulin as mealtime insulin within 30 days prior to screening.
  • Using an insulin pump during the last 6 months before screening.
  • History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
  • Pregnant or breast-feeding women or planning pregnancy during the duration of the study.
  • Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever is longer prior to screening.
  • Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
  • Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688933


  Show 104 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02688933     History of Changes
Other Study ID Numbers: LPS14587
U1111-1176-0936 ( Other Identifier: UTN )
First Submitted: February 18, 2016
First Posted: February 23, 2016
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Insulin Glargine
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Aspart
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs