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NCT03751657 · ClinicalTrials.gov registry record · Phase 2
A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
NCT03751657: Completed Phase 2 study, sponsored by Novo Nordisk A/S.
NCT03751657 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 247 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03751657, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
Study Summary
The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.
Primary Outcome
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i.
Interventions
- DRUG Metformin
- DRUG Insulin icodec
- DRUG Insulin glargine
- DRUG Placebo (insulin 287)
- DRUG Dipeptidyl peptidase-4 inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2020-01-17 |
| Phase | Phase 2 |
What the finished NCT03751657 record still lists
NCT03751657 is an interventional study that assigns participants to a tested intervention. The registered 247 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 (86% higher).
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT03751657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03751657 about?
NCT03751657 is a clinical study titled "A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.". The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe...
What is the current status of trial NCT03751657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2018-11-29. Estimated completion is 2020-01-17.
What interventions are being tested in trial NCT03751657?
The interventions under investigation include: Metformin (DRUG), Insulin icodec (DRUG), Insulin glargine (DRUG), Placebo (insulin 287) (DRUG), Dipeptidyl peptidase-4 inhibitors (DRUG).
Who is sponsoring clinical trial NCT03751657?
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 NCT03751657's enrollment target sits among peer trials
247 234th of 2000 higher than 1,767 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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