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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836704
• Other study ID #: LANTUL07191
• Secondary ID: U1111-1172-2903
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2016
• Est. completion date: April 26, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Description:

The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 892
• Est. completion date: April 26, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous injection
• metformin
Pharmaceutical form: table or capsule Route of administration: oral administration
• acarbose
Pharmaceutical form: table or capsule Route of administration: oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with at least one episode of hypoglycemia		16 weeks
Secondary	Percentage of patients achieving HbA1c <7%		16 weeks
Secondary	Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)		16 weeks
Secondary	Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)		16 weeks
Secondary	Change from baseline in HbA1c		Baseline, 16 weeks
Secondary	Change from baseline in Fasting Plasma Glucose		Baseline, 16 weeks
Secondary	Change from baseline in Post Prandial Glucose		Baseline, 16 weeks
Secondary	Change in body weight		Baseline, 16 weeks
Secondary	- Change in insulin dose		Baseline, 16 weeks
Secondary	Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [=3.9 mmol/L])		Baseline, 16 weeks
Secondary	Number of nocturnal hypoglycemic events		Baseline, 16 weeks
Secondary	Number of severe hypoglycemic events		Baseline, 16 weeks