A Phase 3 interventional study of Insulin glargine/Lixisenatide and Insulin glargine (HOE901) in Type 2 Diabetes Mellitus, sponsored by Sanofi. Terminated at 85 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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Among 176 studies testing Insulin Glargine in Diabetes Mellitus, Type 2 — 4 open to participants now, 6 under way, 1 of them phase 3. Insulin Glargine · Diabetes Mellitus, Type 2.
Among the 176 studies testing Insulin Glargine in Diabetes Mellitus, Type 2, this one is the 94th largest by enrollment of the 175 interventional ones that give a count, is one of 7 that started in 2018, is one of 60 in phase 3, and was the 146th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →4 of the 176 studies testing Insulin Glargine in Diabetes Mellitus, Type 2 are open now, in 2 countries. Recruiting first, the newest first:
Sanofi · Sites in China
Ages 18+
Loyola University · Sites in United States
Ages 18+ · Women only
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 30–65
Yanbing Li
Ages 18–70
By country, each count listing its studies:
Insulin Glargine: first FDA approval 2000 (LANTUS SOLOSTAR), first EMA approval 2000. What it is approved for, and how studies give it, is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
176 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 241 is above the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 253 across the 175 interventional studies. Of the 161 that completed or were terminated, 56 (35%) have results posted.
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122 of 176 have an industry lead sponsor. The 10 most frequent:
Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
186 studies in Diabetes Mellitus, Type 2 by Sanofi: 1 open now, 1 under way, none of them phase 3. Of 183 finished, 46 (25%) have results posted.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, this one is the 110th largest by enrollment of the 178 interventional ones that give a count, is one of 12 that started in 2018, is one of 80 in phase 3, and was the 160th registered.
Sanofi’s Diabetes Mellitus, Type 2 studies by the year they started, since 2000.
1 of the studies testing Insulin Glargine in Diabetes Mellitus, Type 2 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07173712Yanbing LiRegimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes | 2027-06-30 |
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Among the 176 studies testing Insulin Glargine in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Sanofi’s 186 in Diabetes Mellitus, Type 2:
Nothing recorded among them since 2026-09-25.
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Primary Objective:
Secondary Objective:
The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
Drug: Insulin glargine/Lixisenatide · Drug: Background therapy
Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Drug: Insulin glargine (HOE901) · Drug: Background therapy
Drug pages: Insulin Glargine · Lixisenatide
Insulin glargine (100 units per milliliter \[U/mL\]) and lixisenatide (33 micrograms per milliliter \[mcg/mL\]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.
Also known as: Soliqua 100/33, HOE901/AVE0010
Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.
Also known as: Lantus, HOE901
Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
Time frame: Baseline, Week 26
Percentage of Participants Achieving HbA1c Target of <7% at Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Time frame: Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.
Time frame: Baseline, Week 26
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Daily Insulin Glargine Dose at Week 26
Change in daily dose was calculated by subtracting baseline value from Week 26 value.
Time frame: Baseline, Week 26
Change From Baseline in Body Weight at Week 26
Change in body weight was calculated by subtracting baseline value from Week 26 value.
Time frame: Baseline, Week 26
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<54 mg/dL (3.0 mmol/L) regardless of symptoms.
Time frame: Baseline to Week 26
The study was conducted at 94 sites in United States (US). A total of 534 participants were screened between 20 February 2018 and 01 November 2018, of which 293 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level less than (\<)7.5% or greater than (\>)10% at the screening visit.
| Milestone | Soliqua 100/33 | Lantus |
|---|---|---|
| Started | 116 | 125 |
| Treated | 115 | 125 |
| Completed | 9 | 12 |
| Not completed | 107 | 113 |
| Withdrew: Randomized but not treated | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Poor compliance to protocol | 0 | 1 |
| Withdrew: Study terminated by sponsor | 91 | 102 |
| Withdrew: Withdrawal by subject | 7 | 5 |
| Withdrew: Other than specified | 7 | 5 |
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
| percentage of HbA1c | Soliqua 100/33 | Lantus |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 | -1.86 ± 0.96 | -1.07 ± 1.17 |
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
| percentage of participants | Soliqua 100/33 | Lantus |
|---|---|---|
| Percentage of Participants Achieving HbA1c Target of <7% at Week 26 | 52.6 | 30.8 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Change in daily dose was calculated by subtracting baseline value from Week 26 value.
| International Units (IU) | Soliqua 100/33 | Lantus |
|---|---|---|
| Change From Baseline in Daily Insulin Glargine Dose at Week 26 | 18.7 ± 16.4 | 14.1 ± 16.5 |
Change in body weight was calculated by subtracting baseline value from Week 26 value.
| kilograms (kg) | Soliqua 100/33 | Lantus |
|---|---|---|
| Change From Baseline in Body Weight at Week 26 | 1.69 ± 3.74 | 1.52 ± 2.92 |
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<54 mg/dL (3.0 mmol/L) regardless of symptoms.
| percentage of participants | Soliqua 100/33 | Lantus |
|---|---|---|
| Any hypoglycemia | 48.7 | 52.8 |
| Severe hypoglycemia | 1.7 | 2.4 |
| Documented hypoglycaemia <=70 mg/dL (3.9 mmol/L) | 43.5 | 48.8 |
| Documented hypoglycaemia <54 mg/dL (3.0 mmol/L) | 12.2 | 18.4 |
Collected over All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Soliqua 100/33 | 0/115 (0%) | 7/115 (6.1%) | 21/115 (18.3%) |
| Lantus | 0/125 (0%) | 4/125 (3.2%) | 20/125 (16%) |
| Event | Soliqua 100/33 | Lantus |
|---|---|---|
| Acute Myocardial InfarctionCardiac disorders | 1/115 | 0/125 |
| Atrial FibrillationCardiac disorders | 1/115 | 0/125 |
| Cardiac Failure CongestiveCardiac disorders | 1/115 | 0/125 |
| Coronary Artery DiseaseCardiac disorders | 1/115 | 0/125 |
| Myocardial InfarctionCardiac disorders | 1/115 | 0/125 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/115 | 0/125 |
| Invasive Ductal Breast CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/115 | 0/125 |
| Facial ParalysisNervous system disorders | 1/115 | 0/125 |
| AnaemiaBlood and lymphatic system disorders | 0/115 | 1/125 |
| Angina UnstableCardiac disorders | 0/115 | 1/125 |
| Event | Soliqua 100/33 | Lantus |
|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 3/115 | 10/125 |
| DiarrhoeaGastrointestinal disorders | 8/115 | 3/125 |
| NauseaGastrointestinal disorders | 8/115 | 2/125 |
| HeadacheNervous system disorders | 7/115 | 8/125 |
| VomitingGastrointestinal disorders | 6/115 | 2/125 |
Analysis was performed on randomized population.
| Age, Continuous(years) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Mean | 61.6 ± 9.7 | 57.7 ± 11.9 | 59.6 ± 11.1 |
| Sex: Female, Male(Participants) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Female | 57 | 67 | 124 |
| Male | 59 | 58 | 117 |
| Race/Ethnicity, Customized(Participants) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Hispanics of any race | 60 | 64 | 124 |
| Non-Hispanic black or African Americans | 39 | 40 | 79 |
| Non-Hispanic Asians | 17 | 21 | 38 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Mean | 30.90 ± 4.74 | 30.67 ± 4.93 | 30.78 ± 4.83 |
| Duration of Diabetes(Participants) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| <10 years | 26 | 39 | 65 |
| >=10 years | 90 | 86 | 176 |
| Glycated Haemoglobin (HbA1c %)(percentage of hemoglobin) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Mean | 8.62 ± 0.74 | 8.62 ± 0.68 | 8.62 ± 0.71 |
| Body Weight(kilograms (kg)) | Soliqua 100/33 | Lantus | Total |
|---|---|---|---|
| Mean | 84.97 ± 15.89 | 84.84 ± 19.34 | 84.90 ± 17.73 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Ran from Feb 2018 to primary completion in Jan 2019, 10 months.
Results were first posted in Jan 2020, 1 year after primary completion.
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin Glargine · Lixisenatide