Linagliptin as Add on to Basal Insulin in the Elderly
- Registration Number
- NCT02240680
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed.
In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo patient to receive a tablet of placebo matching linagliptin 5 mg linagliptin 5 mg linagliptin patient to receive a tablet of linagliptin 5 mg each day
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. Baseline and Week 24 This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value. 24 weeks Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.
Percentage of Patients With HbA1c<8.0% 24 weeks This is the percentage of patients with HbA1c on treatment \<8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
Percentage of Patients With HbA1c on Treatment <7.0% 24 weeks This is the percentage of patients with HbA1c on treatment \<7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
Percentage of Patients With HbA1c Lowering by at Least 0.5%. 24 weeks The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
Change From Baseline in Fasting Plasma Glucose (FPG) Baseline and Week 24 This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication
Trial Locations
- Locations (145)
Syed Research Consultants, LLC
🇺🇸Sheffield, Alabama, United States
Precision Research Institute, LLC
🇺🇸Chula Vista, California, United States
Aurora Care Clinic, LLC
🇺🇸Costa Mesa, California, United States
Prime Care Clinical Research
🇺🇸Laguna Hills, California, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Internal Medicine of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Cohen Medical Research Associates, LLC
🇺🇸Delray Beach, Florida, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Clinical Research of Hollywood
🇺🇸Hollywood, Florida, United States
East Coast Institute for Research LLC at NE FL Endo & Diabetes
🇺🇸Jacksonville, Florida, United States
Scroll for more (135 remaining)Syed Research Consultants, LLC🇺🇸Sheffield, Alabama, United States