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NCT03687827 · ClinicalTrials.gov registry record · Phase 4
A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
A Phase 4 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 4
- Development phase
- 498
- Enrollment target
NCT03687827 is a Phase 4 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 498 participants.
The verdict
NCT03687827, a Phase 4 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 498 participants
- Enrollment target
Study Summary
This study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chance. Both medicines are approved for use in humans and available on the market. They can already be prescribed by participants' doctors. Participants will get pre-filled insulin pens to inject these insulins with. The study will last for about 41 weeks. Participants will visit the clinic 13 times and have 27 phone calls with the study doctor or study staff. At 12 of the clinic visits they will take blood samples. In order to evaluate the changes in participants' blood sugar level over time, participants will be asked to wear a small (35 millimetres (mm) x 5 mm) sensor on the back of participants' upper arm 3 times during the study. Each time participants must wear the sensor for 2 weeks. This sensor is called FreeStyle Libre Pro®. It has a very small tip which is 0.4 mm thick and is inserted 5 mm under participants' skin. Please note that participants will not be able to see the sensor readings while wearing it. The study doctor will show participants the readings when participants return to the clinic. Participants will be asked to fill in a diary in between visits. Participants will have contact with the study doctor or study staff each week. This is to adjust the dose of participants' study medicines and to ensure that participants are well. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Interventions
- DRUG Insulin glargine
- DRUG Insulin degludec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2019-12-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03687827
The ClinicalTrials.gov registry entry for NCT03687827 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 498 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Insulin glargine is the first listed.
NCT03687827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03687827 about?
NCT03687827 is a clinical study titled "A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study". This study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chan...
What is the current status of trial NCT03687827?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 498 participants. The study started on 2018-10-02. Estimated completion is 2019-12-27.
What interventions are being tested in trial NCT03687827?
The interventions under investigation include: Insulin glargine (DRUG), Insulin degludec (DRUG).
Who is sponsoring clinical trial NCT03687827?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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