Linagliptin as Add on to Basal Insulin in the Elderly
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|ClinicalTrials.gov Identifier: NCT02240680|
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: placebo Drug: linagliptin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control|
|Actual Study Start Date :||September 23, 2014|
|Actual Primary Completion Date :||April 18, 2017|
|Actual Study Completion Date :||April 25, 2017|
Experimental: linagliptin 5 mg
patient to receive a tablet of linagliptin 5 mg each day
5 mg once a day
Placebo Comparator: placebo
patient to receive a tablet of placebo matching linagliptin 5 mg
placebo matching linagliptin 5 mg
- Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. [ Time Frame: 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.
- Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value. [ Time Frame: 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% [ Time Frame: 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% [ Time Frame: 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%. [ Time Frame: 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) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240680
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|