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Insulin

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

Phase 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline week 0 (visit 2) to week 21 (visit 20)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Diabetes
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline week 0 (visit 2) to week 21 (visit 20)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline week 0 (visit 2) to week 21 (visit 20) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring)
Secondary study objectives
Change in Body Weight
Change in Fasting Plasma Glucose (FPG)
Change in HbA1c (Glycated Haemoglobin)
+5 more

Side effects data

From 2022 Phase 3 trial • 588 Patients • NCT04795531
8%
COVID-19
5%
Diabetic retinopathy
5%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin Icodec
Insulin Degludec

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Insulin 287 algorithm CExperimental Treatment1 Intervention
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Group II: Insulin 287 algorithm BExperimental Treatment1 Intervention
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Group III: Insulin 287 algorithm AExperimental Treatment1 Intervention
Controlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).
Group IV: Insulin Glargine algorithm DActive Control1 Intervention
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin icodec
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,646,302 Total Patients Enrolled
647 Trials studying Diabetes
757,138 Patients Enrolled for Diabetes
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
103,053 Total Patients Enrolled
6 Trials studying Diabetes
1,628 Patients Enrolled for Diabetes
~31 spots leftby Dec 2025