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Trial record 1 of 83 for:    "REACH" AND "Toujeo"
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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin (Reach-Control)

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ClinicalTrials.gov Identifier: NCT02967224
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

  • To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
  • To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
  • Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia).
  • Change in fasting plasma glucose (FPG).
  • Change in body weight.
  • Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
  • Change in hypoglycemic control subscale (HCS)
  • Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: insulin glargine (U300) Drug: insulin glargine (U100) Drug: NPH insulin Drug: insulin detemir Drug: insulin degludec Phase 4

Detailed Description:
The total study duration will be up to 55 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 705 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension
Study Start Date : November 5, 2015
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Toujeo
Toujeo will be administered once daily in addition to noninsulin antidiabetic agents
Drug: insulin glargine (U300)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901; Toujeo

Active Comparator: "Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
Drug: insulin glargine (U100)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901; Lantus

Drug: NPH insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Humulin NPH

Drug: insulin detemir

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Levemir

Drug: insulin degludec

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Tresiba




Primary Outcome Measures :
  1. Change in HbA1c (percentage %) [ Time Frame: Baseline to 6 Months ]

Secondary Outcome Measures :
  1. Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy) [ Time Frame: At Month 6 and Month 12 ]
  2. Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not [ Time Frame: At Month 6 and Month 12 ]
  3. Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%) [ Time Frame: At Month 6 and Month 12 ]
  4. Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dL [3.9 mmol/L]) symptomatic or severe hypoglycemia [ Time Frame: At Month 6 and Month 12 ]
  5. Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dL [3.0 mmol/L]) symptomatic or severe hypoglycemia [ Time Frame: At Month 6 and Month 12 ]
  6. Change in HbA1c (percentage %) [ Time Frame: Baseline to Month 12 ]
  7. Percentage of patients whose HbA1c decreased at least 1% [ Time Frame: At Month 6 and Month 12 ]
  8. Percentage of patients whose HbA1c decreased at least 1% [ Time Frame: At Month 6 and maintained at Month 12 ]
  9. Percentage of patients requiring intensification [ Time Frame: At Month 6 and Month 12 ]
  10. Time to intensification [ Time Frame: At Month 6 and Month 12 ]
  11. Change in fasting plasma glucose [ Time Frame: Baseline to Month 6 and Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (≥6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinediones, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without GLP-1 receptor agonist, and eligible to basal insulin treatment, per investigator's judgment.

Exclusion criteria:

  • HbA1c ≤7%, no upper bound.
  • Age <18 years.
  • Type 1 diabetes mellitus.
  • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, 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.
  • Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization.
  • Use of any product containing insulin occurring within 3 months prior to the time of screening.
  • Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP 1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
  • All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
  • Hypersensitivity to insulin glargine or Toujeo excipients.
  • Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Pregnancy or lactation.
  • Women of childbearing potential with no effective contraceptive method.

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


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): NCT02967224


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02967224    
Other Study ID Numbers: LPS13931
2015-001831-18 ( EudraCT Number )
U1111-1170-8104 ( Other Identifier: UTN )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 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:
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Insulin Glargine
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs