A Phase 4 interventional study of INSULIN GLARGINE (HOE901) and Insulin Glulisine in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 4, 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 61st largest by enrollment of the 175 interventional ones that give a count, is one of 7 that started in 2018, is one of 103 in phase 4, and was the 145th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 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 882 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; 203 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
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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 384 is above the median of 80 across 8,356 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; 90 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 74th largest by enrollment of the 178 interventional ones that give a count, is one of 12 that started in 2018, is one of 75 in phase 4, and was the 156th 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:
To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.
Secondary Objectives:
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
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 patient'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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug: INSULIN GLARGINE (HOE901) · Drug: Insulin Glulisine · Drug: Repaglinide · Drug: Acarbose
Twice daily premixed insulin
Drug: Biphasic insulin aspart 30 · Drug: Metformin
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Also known as: Lantus
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Also known as: Apidra
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Also known as: Novolog Mix70/30
Pharmaceutical form: tablet Route of administration: oral administration
Also known as: NovoNorm
Pharmaceutical form: tablet Route of administration: oral administration
Also known as: Glucobay
Pharmaceutical form: tablet or capsule Route of administration: oral administration
Change in hemoglobin A1c (HbA1c)
Change in HbA1c from baseline to week 24
Time frame: Baseline to Week 24
Patients with fasting plasma glucose (FPG) <6.1 mmol/L
Percentage of patients with FPG \<6.1 mmol/L at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with FPG <6.1 mmol/L without hypoglycemia
Percentage of patients with FPG \<6.1 mmol/L without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with FPG <7 mmol/L
Percentage of patients with FPG \<7 mmol/L at week 12 and week 2
Time frame: At Week 12 and Week 24
Patients with FPG <7 mmol/L without hypoglycemia
Percentage of patients with FPG \<7 mmol/L without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with HbA1c <7%
Percentage of patients with HbA1c \<7% at week 12 and week 24
Time frame: At Week 12 and Week 24
Patients with HbA1c <7% without hypoglycemia
Percentage of patients with HbA1c \<7% without hypoglycemia at week 12 and week 24
Time frame: At Week 12 and Week 24
Hypoglycemic events
Incidence of hypoglycemia during treatment period
Time frame: Baseline to Week 24
Change in FPG
Change in FPG from baseline to week 24
Time frame: Baseline to Week 24
Change in body weight
Change in body weight from baseline to week 24
Time frame: Baseline to Week 24
Insulin dose
Total daily insulin dose at week 24
Time frame: At Week 24
Daily BG variation at week 24
Daily blood glucose (BG) variation at week 24
Time frame: At Week 24
European quality of life - 5 dimensions (EQ-5D)
Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem.
Time frame: Baseline to Week 24
Subgroup analysis
Subgroup analysis of control rate of HbA1c \<7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period
Time frame: At week 24
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 Jan 2018 to primary completion in Jun 2020, 29 months.
Of 132 industry-sponsored phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 29 months is above that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 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 · Insulin glulisine · Repaglinide · Acarbose