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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02451137
First Posted: May 21, 2015
Last Update Posted: October 17, 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:

Demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets (<8% if age 65 years or with defined comorbidities (as listed in Appendix G) or otherwise <7%) at 6 months without documented symptomatic (BG 70mg/dl) hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive patients with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 and 12 months after initiating insulin therapy in a real world setting in terms of:

  • Patient persistence with assigned basal insulin therapy
  • Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia
  • Changes in HbA1c, fasting plasma glucose, body weight
  • Differences in patient- and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions DTSQs and DTSQc), Hypoglycemia Patient Questionnaire, and patient and provider reported Global Effectiveness Scale (GES)
  • Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE (U300) Drug: INSULIN GLARGINE (U100) Drug: Insulin detemir (Levemir) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • - Proportion of patients with individualized HbA1c target attainment per HEDIS criteria (<8% if age ≥65 years or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic (BG ≤70 mg/dL) hypoglycemia [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures:
  • Change in HbA1c from baseline (obtained at screening visit within one week of study initiation) [ Time Frame: Baseline to 6 months ]
  • Proportion of patients with documented symptomatic (BG ≤70 mg/dL) nocturnal (midnight to 5:59 am) hypoglycemia [ Time Frame: Baseline to 6 months ]
  • Proportion of patients with documented symptomatic (BG ≤70 mg/dL) 24-hour hypoglycemia [ Time Frame: Baseline to 6 months ]

Estimated Enrollment: 3324
Actual Study Start Date: June 16, 2015
Estimated Study Completion Date: July 17, 2018
Estimated Primary Completion Date: January 16, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toujeo
Toujeo once daily on top of non-insulin antidiabetic agents in a real world setting
Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Toujeo
Active Comparator: Levemir or Lantus
Levemir or Lantus once or twice daily according to label on top of non-insulin antidiabetic agents in a real world setting
Drug: INSULIN GLARGINE (U100)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus
Drug: Insulin detemir (Levemir)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Levemir

Detailed Description:
The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension 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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with T2DM, as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 [DPP-4] inhibitors, or sodium-glucose cotransporter 2 [SGLT-2] inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for use with insulin.
  • Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

  • HbA1c <8.0% or >11.0%.
  • Males or females <18 years of age.
  • 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 (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization.
  • Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) 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, or 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.
  • 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.

  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): NCT02451137


  Show 472 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02451137     History of Changes
Other Study ID Numbers: LPS14347
U1111-1168-0354 ( Other Identifier: UTN )
First Submitted: May 19, 2015
First Posted: May 21, 2015
Last Update Posted: October 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs