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NCT03429543 · ClinicalTrials.gov registry record · Phase 3
Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT03429543 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 175 participants.
The verdict
NCT03429543, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Whi
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Empagliflozin
- DRUG Insulin
- DRUG Linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03429543
The ClinicalTrials.gov registry entry for NCT03429543 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03429543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03429543 about?
NCT03429543 is a clinical study titled "Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM". The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve...
What is the current status of trial NCT03429543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2018-03-20. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT03429543?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Empagliflozin (DRUG), Insulin (DRUG), Linagliptin (DRUG).
Who is sponsoring clinical trial NCT03429543?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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