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NCT02451137 · ClinicalTrials.gov registry record · Phase 4
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 3,304
- Enrollment target
- 20
- Study locations
NCT02451137 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 3,304 participants, below the 4,476-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT02451137, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3,304 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Insulin detemir
- DRUG Insulin glargine, 300 U/ml
- DRUG Insulin glargine, 100 U/ml
- DRUG Background Therapy
Study Locations (20)
Alabama
- Investigational Site Number 840731 - Birmingham
- Investigational Site Number 840305 - Birmingham
- Investigational Site Number 840811 - Birmingham
- Investigational Site Number 840218 - Gulf Shores
- Investigational Site Number 840739 - Guntersville
- Investigational Site Number 840367 - Huntsville
- Investigational Site Number 840130 - Montgomery
- Investigational Site Number 840729 - Montgomery
- Investigational Site Number 840281 - Saraland
- Investigational Site Number 840613 - Sheffield
- Investigational Site Number 840634 - Sheffield
- Investigational Site Number 840654 - Sheffield
Arkansas
- Investigational Site Number 840725 - Conway
- Investigational Site Number 840790 - Jonesboro
- Investigational Site Number 840699 - Little Rock
- Investigational Site Number 840528 - Little Rock
- Investigational Site Number 840079 - Searcy
Arizona
- Investigational Site Number 840173 - Phoenix
- Investigational Site Number 840555 - Phoenix
- Investigational Site Number 840805 - Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,304 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02451137
The ClinicalTrials.gov registry entry for NCT02451137 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3,304 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,476-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (26% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Insulin detemir is the first listed.
NCT02451137 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT02451137 about?
NCT02451137 is a clinical study titled "A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)". 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 (B...
What is the current status of trial NCT02451137?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,304 participants. The study started on 2015-06-16. Estimated completion is 2018-08-09.
What conditions does trial NCT02451137 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT02451137?
The interventions under investigation include: Insulin detemir (DRUG), Insulin glargine, 300 U/ml (DRUG), Insulin glargine, 100 U/ml (DRUG), Background Therapy (DRUG).
Who is sponsoring clinical trial NCT02451137?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02451137 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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