A Phase 3 interventional study of Insulin glargine/lixisenatide fixed ratio combination and liraglutide in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 124 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.
Secondary Objectives:
To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes.
To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.
Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.
All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 514 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria :
in combination with metformin (daily dose greater than equal to [>=] 1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.
or
Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;
-Signed written informed consent.
Exclusion criteria:
Exclusion criteria for the extension period:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.
Drug: Insulin glargine/lixisenatide fixed ratio combination · Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \[BID\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
Drug: liraglutide · Drug: exenatide · Drug: exenatide extended-release · Drug: albiglutide · Drug: dulaglutide · Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Drug pages: Insulin Glargine · Lixisenatide
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: HOE901/AVE0010, Soliqua
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Victoza
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Byetta
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Bydureon
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Tanzeum
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Trulicity
Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
Time frame: Baseline, Week 26
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
Time frame: Baseline, Week 52
Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period
Participants without any available HbA1c assessment at Week 26 were considered as non-responders.
Time frame: Week 26
Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period
Participants without any available HbA1c assessment at Week 52 were considered as non-responders.
Time frame: Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.
Time frame: Baseline, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period
Change in FPG was calculated by subtracting baseline value from Week 52 value.
Time frame: Baseline, Week 52
Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.
Time frame: Baseline, Week 26
Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.
Time frame: Baseline, Week 52
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).
Time frame: Baseline, Week 26
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.
Time frame: Baseline, Week 52
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.
Time frame: Baseline, Week 26
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.
Time frame: Baseline, Week 52
Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%.
Time frame: From Baseline to Week 26
Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%.
Time frame: From Week 26 to Week 52
Change From Baseline in Body Weight at Week 26: Core Period
Change in body weight was calculated by subtracting baseline value from Week 26 value.
Time frame: Baseline, Week 26
Change From Baseline in Body Weight to Week 52: Single Arm Extension Period
Change in body weight was calculated by subtracting baseline value from Week 52 value.
Time frame: Baseline, Week 52
Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed.
Time frame: From Baseline to Week 26
Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed.
Time frame: From Baseline to Week 52
The study was conducted at 112 sites in 9 countries. A total of 840 participants were screened between 06 July 2016 and 01 November 2017, of which 326 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level lesser than (\<)7% or more than (\>)9% at screening visit.
| Milestone | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Started | 257 | 257 |
| Treated | 255 | 256 |
| Completed | 230 | 246 |
| Not completed | 27 | 11 |
| Withdrew: Adverse event | 10 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Poor compliance to protocol | 2 | 0 |
| Withdrew: Withdrawal by subject | 9 | 9 |
| Withdrew: Randomized but not treated | 2 | 1 |
| Withdrew: Other than specified | 3 | 1 |
| Milestone | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Started | 206 | 0 |
| Completed | 197 | 0 |
| Not completed | 9 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Poor compliance to protocol | 3 | 0 |
| Withdrew: Other than specified | 5 | 0 |
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
| percentage of HbA1c | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period | -1.02 ± 0.048 | -0.38 ± 0.048 |
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
| percentage of HbA1c | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period | -1.01 ± 0.063 |
Participants without any available HbA1c assessment at Week 26 were considered as non-responders.
| percentage of participants | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| HbA1c <7% | 61.9 | 25.7 |
| HbA1c <=6.5% | 40.5 | 9.9 |
Participants without any available HbA1c assessment at Week 52 were considered as non-responders.
| percentage of participants | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| HbA1c <7% | 64.1 |
| HbA1c <=6.5% | 42.7 |
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.
| millimoles per litre (mmol/L) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period | -2.28 ± 0.120 | -0.60 ± 0.119 |
Change in FPG was calculated by subtracting baseline value from Week 52 value.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period | -2.27 ± 0.173 |
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period | -1.69 ± 0.114 | -0.67 ± 0.112 |
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period | -1.68 ± 0.176 |
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period | -3.96 ± 0.211 | -1.11 ± 0.205 |
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period | -4.30 ± 0.284 |
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period | -1.51 ± 0.177 | -0.52 ± 0.173 |
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.
| mmol/L | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period | -1.85 ± 0.209 |
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%.
| percentage of participants | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period | 4.8 | 15.0 |
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%.
| percentage of participants | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period | 1.5 |
Change in body weight was calculated by subtracting baseline value from Week 26 value.
| kilogram (kg) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Change From Baseline in Body Weight at Week 26: Core Period | 1.89 ± 0.222 | -1.14 ± 0.220 |
Change in body weight was calculated by subtracting baseline value from Week 52 value.
| kg | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Change From Baseline in Body Weight to Week 52: Single Arm Extension Period | 2.78 ± 0.294 |
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed.
| events per participant-year | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist |
|---|---|---|
| Documented symptomatic hypoglycemia(<=3.9 mmol/L) | 1.54 | 0.08 |
| Documented symptomatic hypoglycemia (<3.0 mmol/L) | 0.25 | 0.01 |
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed.
| events per participant-year | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) |
|---|---|
| Documented symptomatic hypoglycemia(<=3.9 mmol/L) | 1.59 |
| Documented symptomatic hypoglycemia (<3.0 mmol/L) | 0.24 |
Collected over All Adverse Events (AEs) were collected from signature of informed consent until the end of the study (up to 52 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fixed Ratio Combination | 0/255 (0%) | 10/255 (3.9%) | 69/255 (27.1%) |
| GLP-1 Receptor Agonist | 0/256 (0%) | 9/256 (3.5%) | 48/256 (18.8%) |
| Fixed Ratio Combination Whole Study Period | 1/206 (0.5%) | 21/206 (10.2%) | 75/206 (36.4%) |
| Event | Fixed Ratio Combination | GLP-1 Receptor Agonist | Fixed Ratio Combination Whole Study Period |
|---|---|---|---|
| Cardiac Failure CongestiveCardiac disorders | 0/255 | 0/256 | 2/206 |
| Coronary Artery DiseaseCardiac disorders | 0/255 | 0/256 | 2/206 |
| FallInjury, poisoning and procedural complications | 2/255 | 0/256 | 2/206 |
| Subarachnoid HaemorrhageNervous system disorders | 0/255 | 0/256 | 2/206 |
| Arteriosclerosis Coronary ArteryCardiac disorders | 0/255 | 0/256 | 1/206 |
| Atrial FibrillationCardiac disorders | 1/255 | 0/256 | 1/206 |
| Cardiac FailureCardiac disorders | 0/255 | 0/256 | 1/206 |
| Ischaemic CardiomyopathyCardiac disorders | 1/255 | 0/256 | 1/206 |
| Duodenal UlcerGastrointestinal disorders | 0/255 | 0/256 | 1/206 |
| Rectal HaemorrhageGastrointestinal disorders | 1/255 | 0/256 | 1/206 |
| Event | Fixed Ratio Combination | GLP-1 Receptor Agonist | Fixed Ratio Combination Whole Study Period |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 25/255 | 23/256 | 32/206 |
| NauseaGastrointestinal disorders | 22/255 | 6/256 | 19/206 |
| DiarrhoeaGastrointestinal disorders | 14/255 | 6/256 | 15/206 |
| InfluenzaInfections and infestations | 11/255 | 6/256 | 15/206 |
| Upper Respiratory Tract InfectionInfections and infestations | 9/255 | 12/256 | 13/206 |
Analysis was performed on randomized population.
| Age, Continuous(years) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Mean | 59.2 ± 9.6 | 60.0 ± 10.3 | 59.6 ± 10.0 |
| Sex: Female, Male(Participants) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Female | 131 | 113 | 244 |
| Male | 126 | 144 | 270 |
| Race/Ethnicity, Customized(Participants) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian/Oriental | 3 | 4 | 7 |
| Black | 12 | 7 | 19 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 241 | 244 | 485 |
| Unknown or Not Reported' | 0 | 2 | 2 |
| Body Mass Index (BMI)(Participants) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| <30 | 71 | 69 | 140 |
| >=30 | 186 | 188 | 374 |
| Duration of diabetes(years) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Mean | 11.23 ± 7.42 | 10.95 ± 6.08 | 11.09 ± 6.78 |
| Hemoglobin A1C (HbA1C)(percentage of HbA1c) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Mean | 7.78 ± 0.62 | 7.80 ± 0.56 | 7.79 ± 0.59 |
| Daily dose of metformin at baseline(milligrams (mg)) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Mean | 1966.93 ± 434.56 | 2030.74 ± 497.15 | 1998.83 ± 467.54 |
| Daily dose of pioglitazone at baseline(mg) | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | GLP-1 Receptor Agonist | Total |
|---|---|---|---|
| Mean | 31.25 ± 10.03 | 32.73 ± 8.83 | 32.21 ± 9.14 |
3 further baseline measures are reported on the registry.
Showing the first 100 of 124 sites across 9 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Insulin Glargine · Lixisenatide