A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine

NCT ID: NCT03922750

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2020-01-27

Brief 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 switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The 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 doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin 287 (with 100% loading dose)

Participants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Insulin 287 (without loading dose)

Participants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Insulin glargine U100

Participants will receive insulin glargine U100 once daily (OD).

Group Type: ACTIVE_COMPARATOR

Insulin glargine U100

Intervention Type: DRUG

Participants will receive s.c. injections of insulin glargine OD for 16 weeks

Interventions

Insulin icodec

Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Intervention Type: DRUG

Insulin glargine U100

Participants will receive s.c. injections of insulin glargine OD for 16 weeks

Intervention Type: DRUG

Other Intervention Names

Insulin 287

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
• Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
• Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
• Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):

1. Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records).

2. Free or fixed combination therapy: Metformin as outlined above with or without dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose.

• Body mass index (BMI) less than or equal to 40.0 kg/m^2.

Exclusion Criteria

• Known or suspected hypersensitivity to trial product(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
• Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
• Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Novo Nordisk Investigational Site

Nashua, New Hampshire, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Renton, Washington, United States

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Novo Nordisk Investigational Site

Surrey, British Columbia, Canada

Novo Nordisk Investigational Site

Vancouver, British Columbia, Canada

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Novo Nordisk Investigational Site

Brampton, Ontario, Canada

Novo Nordisk Investigational Site

Concord, Ontario, Canada

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

Novo Nordisk Investigational Site

Markham, Ontario, Canada

Novo Nordisk Investigational Site

Sarnia, Ontario, Canada

Novo Nordisk Investigational Site

Broumov, , Czechia

Novo Nordisk Investigational Site

Holešov, , Czechia

Novo Nordisk Investigational Site

Hranice, , Czechia

Novo Nordisk Investigational Site

Trutnov, , Czechia

Novo Nordisk Investigational Site

Falkensee, , Germany

Novo Nordisk Investigational Site

Hamburg, , Germany

Novo Nordisk Investigational Site

Ludwigshafen, , Germany

Novo Nordisk Investigational Site

Münster, , Germany

Novo Nordisk Investigational Site

Oldenburg I. Holst, , Germany

Novo Nordisk Investigational Site

Saint Ingbert-Oberwürzbach, , Germany

Novo Nordisk Investigational Site

Bergamo, , Italy

Novo Nordisk Investigational Site

Catanzaro, , Italy

Novo Nordisk Investigational Site

Milan, , Italy

Novo Nordisk Investigational Site

Milan, , Italy

Novo Nordisk Investigational Site

Roma, , Italy

Countries

United States; Canada; Czechia; Germany; Italy

References

Bajaj HS, Bergenstal RM, Christoffersen A, Davies MJ, Gowda A, Isendahl J, Lingvay I, Senior PA, Silver RJ, Trevisan R, Rosenstock J. Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial. Diabetes Care. 2021 Jul;44(7):1586-1594. doi: 10.2337/dc20-2877. Epub 2021 Apr 19.

Reference Type: RESULT

PMID: 33875485 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1219-5541

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003407-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1436-4466

Identifier Type: -

Identifier Source: org_study_id