Trial · NCT02451137
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
NCT02451137, Phase 4, Completed, Sanofi; results first posted 2019-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM). Trials, record NCT02451137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02451137
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
- NCT number
- NCT02451137
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,304 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml, Insulin detemir, Background Therapy
- First posted
- 2015-05-21
- Last updated
- 2019-09-10
- Results first posted
- 2019-05-01
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline to Month 6 | HEDIS criteria: Individualized HbA1c target \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=70 milligrams per deciliter (mg/dL) (\<=3.9 millimoles per litre \[mmol/L\]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier). |
| Secondary | Change From Baseline in HbA1c at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction. |
| Secondary | Treatment Persistence Measured by Medication Possession Ratio (MPR) | At Month 6 and Month 12 | Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period. |
| 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 | Baseline to Month 6 | HEDIS criteria for Individualized HbA1c target: \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (3.0 mmol/L). |
| 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 | Baseline to Month 12 | HEDIS criteria for Individualized HbA1c target: \<8% if age \>= 65 years or presence of medical comorbidities, or otherwise \<7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (\<=70 mg/dL) and \< 3.0 mmol/L (\< 54 mg/dL). |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction. |
| Secondary | Change From Baseline in Body Weight at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (\<8% / \<7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction. |
| Secondary | Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values. |
| 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 | At Month 6, Month 12 | Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported "excellent" or "good" on the GES at Month 6 and Month 12 are reported here. |
| 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 | At Baseline, Month 6, Month 12 | DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline to Month 6 | Analysis was performed on Intent-to-Treat (ITT) population which comprised of all randomized participants, irrespective of the treatment actually received, and analyzed according to the treatment group allocated by randomization. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HbA1c at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Persistence Measured by Medication Possession Ratio (MPR) | At Month 6 and Month 12 | Analysis was performed on safety population. | Medication Possession ratio | MEAN |
| 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 | Baseline to Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| 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 | Baseline to Month 12 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Unit/kg (U/kg) | MEAN |
| 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 | At Month 6, Month 12 | Analysis was performed on ITT population. | percentage of responders | NUMBER |
| 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 | At Baseline, Month 6, Month 12 | Analysis was performed on ITT population. Here, number analyzed = participants with available data for each specified category. | score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Toujeo | 31.3 | percentage of participants | ||
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 | Standard of Care | 27.9 | percentage of participants | ||
| Change From Baseline in HbA1c at Month 6 and Month 12 | Toujeo | Month 6 | -1.40 | Standard Error 0.030 | percentage of HbA1c |
| Change From Baseline in HbA1c at Month 6 and Month 12 | Standard of Care | Month 6 | -1.36 | Standard Error 0.030 | percentage of HbA1c |
| Change From Baseline in HbA1c at Month 6 and Month 12 | Toujeo | Month 12 | -1.29 | Standard Error 0.034 | percentage of HbA1c |
| Change From Baseline in HbA1c at Month 6 and Month 12 | Standard of Care | Month 12 | -1.24 | Standard Error 0.034 | percentage of HbA1c |
| Treatment Persistence Measured by Medication Possession Ratio (MPR) | Toujeo | Month 6 | 62.06 | Standard Deviation 26.98 | Medication Possession ratio |
| Treatment Persistence Measured by Medication Possession Ratio (MPR) | Standard of Care | Month 6 | 63.14 | Standard Deviation 28.42 | Medication Possession ratio |
| Treatment Persistence Measured by Medication Possession Ratio (MPR) | Toujeo | Month 12 | 58.21 | Standard Deviation 28.87 | Medication Possession ratio |
| Treatment Persistence Measured by Medication Possession Ratio (MPR) | Standard of Care | Month 12 | 57.82 | Standard Deviation 29.97 | Medication Possession ratio |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Toujeo | 1,651 | |
| Overall Study | STARTED | Standard of Care | 1,653 | |
| Overall Study | Treated | Toujeo | 1,632 | |
| Overall Study | Treated | Standard of Care | 1,626 | |
| Overall Study | Safety Population | Toujeo | 1,637 | |
| Overall Study | Safety Population | Standard of Care | 1,621 | |
| Overall Study | COMPLETED | Toujeo | 1,405 | |
| Overall Study | COMPLETED | Standard of Care | 1,355 | |
| Overall Study | NOT COMPLETED | Toujeo | 246 | |
| Overall Study | NOT COMPLETED | Standard of Care | 298 |
Source ClinicalTrials.gov
Adverse events562
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Toujeo | 2 | 1,637 | 2 |
| serious | Anaemia | Blood and lymphatic system disorders | Standard of Care Basal Insulin | 1 | 1,621 | 1 |
| serious | Febrile Neutropenia | Blood and lymphatic system disorders | Toujeo | 2 | 1,637 | 3 |
| serious | Febrile Neutropenia | Blood and lymphatic system disorders | Standard of Care Basal Insulin | 1 | 1,621 | 1 |
| serious | Haemorrhagic Anaemia | Blood and lymphatic system disorders | Toujeo | 3 | 1,637 | 3 |
| serious | Haemorrhagic Anaemia | Blood and lymphatic system disorders | Standard of Care Basal Insulin | 2 | 1,621 | 2 |
| serious | Lymphadenitis | Blood and lymphatic system disorders | Toujeo | 1 | 1,637 | 1 |
| serious | Lymphadenitis | Blood and lymphatic system disorders | Standard of Care Basal Insulin | 0 | 1,621 | 0 |
| serious | Lymphadenopathy Mediastinal | Blood and lymphatic system disorders | Toujeo | 0 | 1,637 | 0 |
| serious | Lymphadenopathy Mediastinal | Blood and lymphatic system disorders | Standard of Care Basal Insulin | 1 | 1,621 | 1 |
1 to 10 of 562Source ClinicalTrials.gov
See all 562 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Toujeo | 7 | 1,637 |
| Total, all-cause mortality | Standard of Care Basal Insulin | 4 | 1,621 |
| Total, other adverse events | Toujeo | 0 | 1,637 |
| Total, other adverse events | Standard of Care Basal Insulin | 0 | 1,621 |
| Total, serious adverse events | Toujeo | 161 | 1,637 |
| Total, serious adverse events | Standard of Care Basal Insulin | 165 | 1,621 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Toujeo vs Standard of Care Basal Insulin: deaths from any cause | Trial comparisons |
| Toujeo vs Standard of Care Basal Insulin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02451137
GET https://conductscience.org/api/trials/v1/NCT02451137/results?page=2