Diabetes Mellitus, Type 2Phase 4NCT02836704
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
A Phase 4 study testing INSULIN GLARGINE, metformin and acarbose in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in China.
Trial summary
Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- INSULIN GLARGINE, metformin and acarbose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 892 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2016to 26 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years.
- Type 2 diabetes patients with diabetes diagnosis at least 2 years.
- Continuous treatment with stable doses of 2-3 OADs, for more than three months prior to randomization, among which metformin ≥1.5 g/day or at maximum tolerated dose
- HbA1c >7.5% and ≤11%.
- FPG >9 mmol/L.
- BMI ≥25 and ≤40 kg/m^2.
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- Ability and willingness to perform self-monitoring of blood glucose using the Sponsor-provided glucose meter and to complete the patient diary.
- Willingness and ability to comply with the study protocol.
- Signed informed consent obtained prior any study procedure.
Who cannot join
- Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
- History of hypoglycemia unawareness.
- Unexplained hypoglycemia in the past 6 months.
- Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
- Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma).
- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the previous 12 months.
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- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination or disease history record, in the 2 years prior to study entry.
- Impaired renal function defined as, but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (>2 g/day).
- Active liver disease (alanine transaminase [ALT] greater than two times the upper limit of the reference range, as defined by the local laboratory).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
Primary Objective:
-To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs).
Read more
Secondary Objective:
- To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.
- To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).
- To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).
- To evaluate the insulin doses change.
- To evaluate the weight change.
- To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence.
- To descriptively evaluate the safety profile.
- To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration).
- Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:
- Age
- Duration of diabetes
- Baseline treatment (OAD)
- Baseline HbA1c, FPG and PP
Read the detailed description
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- INSULIN GLARGINE, metformin, acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSULIN GLARGINEDrug
Also called HOE901
Pharmaceutical form: solution
Route of administration: subcutaneous injection
metforminDrug
Pharmaceutical form: table or capsule
Route of administration: oral administration
acarboseDrug
Pharmaceutical form: table or capsule
Route of administration: oral administration
| Study group | Role | What they receive |
|---|---|---|
| Standard initial dose of insulin glargine | Active comparator | Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. Receives: Drug: INSULIN GLARGINE; Drug: metformin; Drug: acarbose |
| Higher initial dose of insulin glargine | Experimental | Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. Receives: Drug: INSULIN GLARGINE; Drug: metformin; Drug: acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one episode of hypoglycemia
Measured: 16 weeks
Secondary outcomes (11)
Percentage of patients achieving HbA1c <7%
Measured: 16 weeks
Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Measured: 16 weeks
Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Measured: 16 weeks
Change from baseline in HbA1c
Measured: Baseline, 16 weeks
Change from baseline in Fasting Plasma Glucose
Measured: Baseline, 16 weeks
Change from baseline in Post Prandial Glucose
Measured: Baseline, 16 weeks
Change in body weight
Measured: Baseline, 16 weeks
- Change in insulin dose
Measured: Baseline, 16 weeks
Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L])
Measured: Baseline, 16 weeks
Number of nocturnal hypoglycemic events
Measured: Baseline, 16 weeks
Number of severe hypoglycemic events
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start9 Sep 2016
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836704
- Sponsor's protocol ID
- LANTUL07191
- Other IDs
- U1111-1172-2903
- Status last verified
- Apr 2022
- First submitted
- 7 Jul 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
Publications
Wan H, Wen B, Wang X, Wang J, Zhang Y, Ning T, Duan B, Li Y, Feng W, Zhang X, Cui N, Ji L. Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study. Diabetes Ther. 2021 Sep;12(9):2359-2369. doi: 10.1007/s13300-021-01112-z. Epub 2021 Jul 21.
PubMed 34286454Ji L, Gao Z, Shi B, Bian R, Yin F, Pang W, Gao H, Cui N. Safety and Efficacy of High Versus Standard Starting Doses of Insulin Glargine in Overweight and Obese Chinese Individuals with Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Medications (Beyond VII): Study Protocol for a Randomized Controlled Trial. Adv Ther. 2018 Jun;35(6):864-874. doi: 10.1007/s12325-018-0717-x. Epub 2018 Jun 5.
PubMed 29873004
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02836704
- Acronym / sponsor ID
- LANTUL07191
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
-To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs).
Secondary Objective:
- To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.
- To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).
- To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).
- To evaluate the insulin doses change.
- To evaluate the weight change.
- To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence.
- To descriptively evaluate the safety profile.
- To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration).
- Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:
- Age
- Duration of diabetes
- Baseline treatment (OAD)
- Baseline HbA1c, FPG and PP
Detailed description
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard initial dose of insulin glargine | Active comparator | Drug: INSULIN GLARGINE, Drug: metformin, Drug: acarboseDose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. |
| Higher initial dose of insulin glargine | Experimental | Drug: INSULIN GLARGINE, Drug: metformin, Drug: acarboseDose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 and ≤ 70 years.
- Type 2 diabetes patients with diabetes diagnosis at least 2 years.
- Continuous treatment with stable doses of 2-3 OADs, for more than three months prior to randomization, among which metformin ≥1.5 g/day or at maximum tolerated dose
- HbA1c >7.5% and ≤11%.
- FPG >9 mmol/L.
Key exclusion criteria (10 listed)
- Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
- History of hypoglycemia unawareness.
- Unexplained hypoglycemia in the past 6 months.
- Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
- Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSULIN GLARGINEAlso: HOE901Pharmaceutical form: solution Route of administration: subcutaneous injection | Drug | Higher initial dose of insulin glargine, Standard initial dose of insulin glargine |
| metforminPharmaceutical form: table or capsule Route of administration: oral administration | Drug | Higher initial dose of insulin glargine, Standard initial dose of insulin glargine |
| acarbosePharmaceutical form: table or capsule Route of administration: oral administration | Drug | Higher initial dose of insulin glargine, Standard initial dose of insulin glargine |
Primary outcome
Percentage of patients with at least one episode of hypoglycemia
Time frame: 16 weeks
11 secondary outcomes
Percentage of patients achieving HbA1c <7%
Time frame: 16 weeks
Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Time frame: 16 weeks
Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)
Time frame: 16 weeks
Change from baseline in HbA1c
Time frame: Baseline, 16 weeks
Change from baseline in Fasting Plasma Glucose
Time frame: Baseline, 16 weeks
Change from baseline in Post Prandial Glucose
Time frame: Baseline, 16 weeks
Change in body weight
Time frame: Baseline, 16 weeks
- Change in insulin dose
Time frame: Baseline, 16 weeks
Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L])
Time frame: Baseline, 16 weeks
Number of nocturnal hypoglycemic events
Time frame: Baseline, 16 weeks
Number of severe hypoglycemic events
Time frame: Baseline, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 34286454Wan H, Wen B, Wang X, Wang J, Zhang Y, Ning T, Duan B, Li Y, Feng W, Zhang X, Cui N, Ji L. Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study. Diabetes Ther. 2021 Sep;12(9):2359-2369. doi: 10.1007/s13300-021-01112-z. Epub 2021 Jul 21.
- Derived from this study: PubMed 29873004Ji L, Gao Z, Shi B, Bian R, Yin F, Pang W, Gao H, Cui N. Safety and Efficacy of High Versus Standard Starting Doses of Insulin Glargine in Overweight and Obese Chinese Individuals with Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Medications (Beyond VII): Study Protocol for a Randomized Controlled Trial. Adv Ther. 2018 Jun;35(6):864-874. doi: 10.1007/s12325-018-0717-x. Epub 2018 Jun 5.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing INSULIN GLARGINE, metformin and acarbose in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with at least one episode of hypoglycemia (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.