Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

NCT ID: NCT02836704

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 892 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-09
• Study Completion Date: 2018-04-26

Brief 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 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard initial dose of insulin glargine

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.

Group Type: ACTIVE_COMPARATOR

INSULIN GLARGINE

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous injection

metformin

Intervention Type: DRUG

Pharmaceutical form: table or capsule

Route of administration: oral administration

acarbose

Intervention Type: DRUG

Pharmaceutical form: table or capsule

Route of administration: oral administration

Higher initial dose of insulin glargine

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.

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous injection

metformin

Intervention Type: DRUG

Pharmaceutical form: table or capsule

Route of administration: oral administration

acarbose

Intervention Type: DRUG

Pharmaceutical form: table or capsule

Route of administration: oral administration

Interventions

INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous injection

Intervention Type: DRUG

metformin

Pharmaceutical form: table or capsule

Route of administration: oral administration

Intervention Type: DRUG

acarbose

Pharmaceutical form: table or capsule

Route of administration: oral administration

Intervention Type: DRUG

Other Intervention Names

HOE901

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

China, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34286454 (View on PubMed)

Ji 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.

Reference Type: DERIVED

PMID: 29873004 (View on PubMed)

Other Identifiers

U1111-1172-2903

Identifier Type: OTHER

Identifier Source: secondary_id

LANTUL07191

Identifier Type: -

Identifier Source: org_study_id