NCT03751657|CompletedPhase 2ResultsFDA Drug

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.

An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN1436-4383U1111-1208-41242018-000322-63

Study Type

interventional

Target

247

Locations

6 countries

Sites

Timeline

RegisteredNov 2018

StartedNov 2018

CompletionJan 2020

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

247

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline

Completed

Started Nov 2018

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach

6 countries

47 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

November 16, 2018

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed

6 days until next milestone

Study Start

First participant enrolled

November 29, 2018

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed

1 year until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed

Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

November 16, 2018

Results QC Date

December 11, 2020

Last Update Submit

March 5, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]
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.
From baseline (Visit 2) to week 26 (Visit 28)
Change in HbA1c [Millimoles/Mole (mmol/Mol)]
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.
From baseline (Visit 2) to week 26 (Visit 28)

Secondary Outcomes (14)

Change in Fasting Plasma Glucose
From baseline (Visit 2) to week 26 (Visit 28)
9-point Profile (Individual SMPG Values)
Week 26 (Visit 28)
Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time
From baseline (Visit 2) to week 26 (Visit 28)
Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).
Week 26 (Visit 28)
Fasting C-peptide
At week 26 (Visit 28)
+9 more secondary outcomes

Study Arms (2)

Insulin 287

EXPERIMENTAL

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.

Drug: Insulin icodecDrug: MetforminDrug: Dipeptidyl peptidase-4 inhibitorsDrug: Placebo (insulin glargine)

Insulin glargine

ACTIVE COMPARATOR

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.

Drug: Placebo (insulin 287)Drug: MetforminDrug: Dipeptidyl peptidase-4 inhibitorsDrug: Insulin glargine

Interventions

Insulin icodecDRUG

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)

Also known as: Insulin 287

Insulin 287

Placebo (insulin 287)DRUG

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

Insulin glargine

MetforminDRUG

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

Insulin 287Insulin glargine

Dipeptidyl peptidase-4 inhibitorsDRUG

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

Insulin 287Insulin glargine

Insulin glargineDRUG

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).

Insulin glargine

Placebo (insulin glargine)DRUG

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

Insulin 287

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
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

Contact the study team to confirm eligibility.