To evaluate the efficacy and safety of linagliptin compared to placebo when added on to insulin therapy alone or in combination with metformin in Chinese patients with type 2 diabetes mellitus with insufficient glycaemic control
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
China-Japan Friendship Hospital
Beijing, China
Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Percentage change from baseline, that is, \[\[(HbA1c after 24 weeks of treatment) - (HbA1c at baseline)\] / (HbA1c at baseline)\] \*100%, where baseline refers to the last observation prior to the start of randomised study drug, including the observation prior to the placebo run-in.
Time frame: Baseline and week 24
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment
Change from baseline in Fasting plasma glucose (FPG) after 24 weeks of treatment.
Time frame: Baseline and week 24
Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment
Change from baseline in 2-hour (2-h) postprandial plasma glucose (PPG) after 24 weeks of treatment.
Time frame: Baseline and week 24
Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment
Percentage of participants with HbA1c on treatment \<7.0 percentage (%) after 24 weeks of treatment. Participants with baseline HbA1c \<7.0% were excluded from the analysis.
Time frame: 24 weeks
Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment
Percentage of participants with HbA1c on treatment \< 6.5% after 24 weeks of treatment. Participants with baseline HbA1c \<6.5% were excluded from the analysis.
Time frame: 24 weeks
Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment
Percentage of participants with HbA1c lowering by at least 0.5% after 24 weeks of treatment.
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Beijing Tongren Hospital
Beijing, China
The General Hospital of Chinese People's Armed Police Forces
Beijing, China
First Hospital of Jilin University
Changchun, China
No.900 Hospital of PLA Joint Logistics Support Force
Fuzhou, China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
General Hospital of Jinan Military Area
Jinan, China
Nanjing First Hospital
Nanjing, China
...and 15 more locations
Time frame: 24 weeks
Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL
Incidence of investigator-reported hypoglycaemic events confirmed by a measured blood glucose ≤70 mg/dL (≤3.9 Millimoles Per Litre (mmol/L)). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
Time frame: 24 weeks
Percentage of Participants With Any Severe Hypoglycaemic AE
Incidence of severe hypoglycaemic events (requiring active assistance by another person, or fatal). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
Time frame: 24 weeks