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.

NCT ID: NCT03751657

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2020-01-17

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Insulin 287

Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)

Metformin

Intervention Type: DRUG

Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

Dipeptidyl peptidase-4 inhibitors

Intervention Type: DRUG

Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

Placebo (insulin glargine)

Intervention Type: DRUG

Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.

Insulin glargine

Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.

Group Type: ACTIVE_COMPARATOR

Placebo (insulin 287)

Intervention Type: DRUG

Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.

Metformin

Intervention Type: DRUG

Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

Dipeptidyl peptidase-4 inhibitors

Intervention Type: DRUG

Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

Insulin glargine

Intervention Type: DRUG

Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).

Interventions

Insulin icodec

Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)

Intervention Type: DRUG

Placebo (insulin 287)

Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.

Intervention Type: DRUG

Metformin

Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

Intervention Type: DRUG

Dipeptidyl peptidase-4 inhibitors

Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

Intervention Type: DRUG

Insulin glargine

Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).

Intervention Type: DRUG

Placebo (insulin glargine)

Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.

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
• HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
• 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): Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record) OR Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with Dipeptidyl peptidase-4 inhibitor (DPP4i) (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records)
• Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
• Body mass index (BMI) less than or equal to 40.0 kg/m^2

• Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Exclusion Criteria

• Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation
• 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
• Presently classified as being in New York Heart Association (NYHA) Class IV

• 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

Lancaster, California, United States

Novo Nordisk Investigational Site

Ventura, California, United States

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Novo Nordisk Investigational Site

Charlotte, North Carolina, United States

Novo Nordisk Investigational Site

Whiteville, North Carolina, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Austin, 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

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

Sarnia, Ontario, Canada

Novo Nordisk Investigational Site

Saint-Marc-des-Carrieres, Quebec, Canada

Novo Nordisk Investigational Site

Brno, , Czechia

Novo Nordisk Investigational Site

Pardubice, , Czechia

Novo Nordisk Investigational Site

Prague, , Czechia

Novo Nordisk Investigational Site

Prague, , Czechia

Novo Nordisk Investigational Site

Prague, , Czechia

Novo Nordisk Investigational Site

Prague, , Czechia

Novo Nordisk Investigational Site

Prague, , Czechia

Novo Nordisk Investigational Site

Rakovník, , Czechia

Novo Nordisk Investigational Site

Slaný, , Czechia

Novo Nordisk Investigational Site

Athens, , Greece

Novo Nordisk Investigational Site

Athens, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Bialystok, , Poland

Novo Nordisk Investigational Site

Gdansk, , Poland

Novo Nordisk Investigational Site

Lodz, , Poland

Novo Nordisk Investigational Site

Poznan, , Poland

Novo Nordisk Investigational Site

Warsaw, , Poland

Novo Nordisk Investigational Site

Wierzchosławice, , Poland

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Novo Nordisk Investigational Site

Košice, , Slovakia

Novo Nordisk Investigational Site

Moldava nad Bodvou, , Slovakia

Novo Nordisk Investigational Site

Šahy, , Slovakia

Novo Nordisk Investigational Site

Trenčín, , Slovakia

Novo Nordisk Investigational Site

Koper, , Slovenia

Novo Nordisk Investigational Site

Ljubljana, , Slovenia

Countries

United States; Canada; Czechia; Greece; Poland; Slovakia; Slovenia

References

Rosenstock J, Bajaj HS, Janež A, Silver R, Begtrup K, Hansen MV, Jia T, Goldenberg R. Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. PMID:32960514

Reference Type: RESULT

Rosenstock J, Bajaj HS, Janez A, Silver R, Begtrup K, Hansen MV, Jia T, Goldenberg R; NN1436-4383 Investigators. Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2020 Nov 26;383(22):2107-2116. doi: 10.1056/NEJMoa2022474. Epub 2020 Sep 22.

Reference Type: DERIVED

PMID: 32960514 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1208-4124

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000322-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1436-4383

Identifier Type: -

Identifier Source: org_study_id