Phase 4
Completed N=3,304
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Source: ClinicalTrials.gov NCT02451137 ↗Enrolled (actual)
3,304
Serious AEs
10.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia — 31.3; 27.9 percentage of participants — p=0.0308
Summary
Primary Objective:
Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets ( =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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia |
31.3; 27.9 | 0.0308 sig |
| SECONDARY Change From Baseline in HbA1c at Month 6 and Month 12 |
-1.40; -1.36; -1.29; -1.24 | — |
| SECONDARY Treatment Persistence Measured by Medication Possession Ratio (MPR) |
62.06; 63.14; 58.21; 57.82 | — |
| SECONDARY Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period |
37.3; 34.3 | — |
| SECONDARY Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period |
26.1; 23.7; 33.0; 29.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 |
-48.9; -50.4; -48.0; -47.3 | — |
| SECONDARY Change From Baseline in Body Weight at Month 6 and Month 12 |
1.02; 1.14; 1.51; 1.40 | — |
| SECONDARY Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 |
0.179; 0.183; 0.222; 0.224 | — |
| SECONDARY Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 |
67.2; 65.6; 62.1; 57.7; 64.7; 64.2 | — |
| SECONDARY Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 |
26.5; 26.4; 31.0; 31.1; 30.9; 30.7 | — |
| SECONDARY Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 |
13.81; 13.79; 0.14; 0.21; -0.82; -0.82 | — |
| SECONDARY Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 |
8.1; 7.5; 11.3; 10.3; 78.3; 74.0 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period |
28.9; 30.4; 8.9; 10.0; 39.1; 41.8 | — |
Eligibility Criteria
Inclusion criteria
- Participants with Type 2 Diabetes Mellitus (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 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin).
- Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.
Exclusion criteria
- HbA1c 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 participant'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, or short-term use during acute event.
- Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, 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 participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02451137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.