MedPath

Linagliptin as Add on to Basal Insulin in the Elderly

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboplacebopatient to receive a tablet of placebo matching linagliptin 5 mg
linagliptin 5 mglinagliptinpatient to receive a tablet of linagliptin 5 mg each day
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.