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NCT02240680 · ClinicalTrials.gov registry record · Phase 4
Linagliptin as Add on to Basal Insulin in the Elderly
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 302
- Enrollment target
NCT02240680: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT02240680 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 302 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02240680, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 302 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG placebo
- DRUG linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2014-09-23 |
| Est. Completion | 2017-04-25 |
| Phase | Phase 4 |
What the finished NCT02240680 record still lists
NCT02240680 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02240680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02240680 about?
NCT02240680 is a clinical study titled "Linagliptin as Add on to Basal Insulin in the Elderly". 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...
What is the current status of trial NCT02240680?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2014-09-23. Estimated completion is 2017-04-25.
What interventions are being tested in trial NCT02240680?
The interventions under investigation include: placebo (DRUG), linagliptin (DRUG).
Who is sponsoring clinical trial NCT02240680?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02240680's enrollment target sits among peer trials
302 266th of 2000 higher than 1,733 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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