A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
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| ClinicalTrials.gov Identifier: NCT02451137 |
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Recruitment Status :
Completed
First Posted : May 21, 2015
Results First Posted : May 1, 2019
Last Update Posted : September 10, 2019
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Insulin glargine, 300 U/ml Drug: Insulin glargine, 100 U/ml Drug: Insulin detemir Drug: Background Therapy | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3304 participants |
| 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 |
| Actual Study Start Date : | June 16, 2015 |
| Actual Primary Completion Date : | March 2, 2018 |
| Actual Study Completion Date : | August 9, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
MedlinePlus related topics:
Hypoglycemia
| Arm | Intervention/treatment |
|---|---|
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Experimental: Toujeo
Toujeo® (Insulin glargine, 300 units per millilitre [U/mL]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program.
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Drug: Insulin glargine, 300 U/ml
Pharmaceutical form: solution Route of administration: subcutaneous Other Name: Toujeo Drug: Background Therapy Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin. |
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Active Comparator: Standard of Care
Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (Insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
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Drug: Insulin glargine, 100 U/ml
Pharmaceutical form: solution Route of administration: subcutaneous Other Name: Lantus Drug: Insulin detemir Pharmaceutical form: solution Route of administration: subcutaneous Other Name: Levemir Drug: Background Therapy Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin. |
Primary Outcome Measures :
- 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 [ Time Frame: 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 Outcome Measures :
- Change From Baseline in HbA1c at Month 6 and Month 12 [ Time Frame: 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.
- Treatment Persistence Measured by Medication Possession Ratio (MPR) [ Time Frame: 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.
- 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 [ Time Frame: 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).
- 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 [ Time Frame: 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).
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 [ Time Frame: 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.
- Change From Baseline in Body Weight at Month 6 and Month 12 [ Time Frame: 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.
- Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 [ Time Frame: Baseline, Month 6, Month 12 ]Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.
- Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 [ Time Frame: 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.
- Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 [ Time Frame: 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.
- Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 [ Time Frame: At Month 12 ]DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).
- Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 [ Time Frame: From Baseline to Month 6 and Month 12 ]Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.
- 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 [ Time Frame: Up to Month 6 and Month 12 ]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 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <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 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.
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
Locations
Show 427 study locations
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Study Documents (Full-Text)
Documents provided by Sanofi:
Documents provided by Sanofi:
Study Protocol [PDF] October 12, 2016
Statistical Analysis Plan [PDF] November 11, 2016
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT02451137 |
| Other Study ID Numbers: |
LPS14347 U1111-1168-0354 ( Other Identifier: UTN ) |
| First Posted: | May 21, 2015 Key Record Dates |
| Results First Posted: | May 1, 2019 |
| Last Update Posted: | September 10, 2019 |
| Last Verified: | August 2019 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin |
Insulin, Globin Zinc Insulin Glargine Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |