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NCT03951805 · ClinicalTrials.gov registry record · Phase 2
A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT03951805: Completed Phase 2 study, sponsored by Novo Nordisk A/S.
NCT03951805 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03951805, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Participants will either get insulin 287 that they will have to inject once a week or insulin glargine that participants will have to inject once a day. Which treatment participants get is decided by chance. The study will last for about 5 months (23 weeks). Participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the study doctor will ask participants to: * measure blood sugar every day with a blood sugar meter using a finger prick. * write down different information in a diary daily and return this to the study doctor. * wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about 4 months) during the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
Primary Outcome
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomis
Interventions
- DRUG Insulin icodec
- DRUG Insulin Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2020-01-17 |
| Phase | Phase 2 |
What the finished NCT03951805 record still lists
NCT03951805 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher).
The record links to 0 conditions, and to 2 interventions - of which Insulin icodec is the first listed.
NCT03951805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03951805 about?
NCT03951805 is a clinical study titled "A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before". This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Particip...
What is the current status of trial NCT03951805?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2019-05-09. Estimated completion is 2020-01-17.
What interventions are being tested in trial NCT03951805?
The interventions under investigation include: Insulin icodec (DRUG), Insulin Glargine (DRUG).
Who is sponsoring clinical trial NCT03951805?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03951805's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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