Linagliptin Add-on to Insulin Background Therapy
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02897349
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description linagliptin linagliptin - linagliptin background therapy - Placebo placebo - Placebo background therapy -
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment Baseline and week 24 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment Baseline and week 24 Change from baseline in Fasting plasma glucose (FPG) after 24 weeks of treatment.
Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment Baseline and week 24 Change from baseline in 2-hour (2-h) postprandial plasma glucose (PPG) after 24 weeks of treatment.
Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment 24 weeks 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.
Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment 24 weeks 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.
Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment 24 weeks Percentage of participants with HbA1c lowering by at least 0.5% after 24 weeks of treatment.
Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL 24 weeks 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.
Percentage of Participants With Any Severe Hypoglycaemic AE 24 weeks 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.
Trial Locations
- Locations (25)
China-Japan Friendship Hospital
🇨🇳Beijing, China
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
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