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

NCT02451137 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3304

Last updated 2019-09-10

Study results available
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Summary

Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants 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 months after initiating insulin therapy in a real world setting in terms of:

* Participant 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 participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).
* Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine, 300 U/ml

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glargine, 100 U/ml

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin detemir

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Background Therapy

Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-16
Primary Completion
2018-03-02
Completion
2018-08-09

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451137 on ClinicalTrials.gov