NCT03922750|CompletedPhase 2ResultsFDA Drug

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

A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1436-4466U1111-1219-55412018-003407-18

Study Type

interventional

Target

154

Locations

5 countries

Sites

Timeline

RegisteredApr 2019

StartedMay 2019

CompletionJan 2020

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

154

participants targeted

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

Timeline

Completed

Started May 2019

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach

5 countries

38 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

9 months study duration

First Submitted

Initial submission to the registry

April 17, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed

17 days until next milestone

Study Start

First participant enrolled

May 9, 2019

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed

12 months until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed

Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

April 17, 2019

Results QC Date

December 11, 2020

Last Update Submit

January 6, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
During the last 2 weeks of treatment (week 15 and 16)

Secondary Outcomes (8)

Change in Glycosylated Haemoglobin (HbA1c)
From baseline week 0 (V2) to week 16 (V18)
Change in Fasting Plasma Glucose (FPG)
From baseline week 0 (V2) to week 16 (V18)
Change in Body Weight
From baseline week 0 (V2) to week 16 (V18)
Weekly Insulin Dose
During the last 2 weeks of treatment (week 15 and 16)
Number of Treatment-emergent Adverse Events (TEAEs)
From baseline week 0 (V2) to week 21 (V20)
+3 more secondary outcomes

Study Arms (3)

Insulin 287 (with 100% loading dose)

EXPERIMENTAL

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.

Drug: Insulin icodec

Insulin 287 (without loading dose)

EXPERIMENTAL

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

Drug: Insulin icodec

Insulin glargine U100

ACTIVE COMPARATOR

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

Drug: Insulin glargine U100

Interventions

Insulin icodecDRUG

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

Also known as: Insulin 287

Insulin 287 (with 100% loading dose)Insulin 287 (without loading dose)

Insulin glargine U100DRUG

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

Insulin glargine U100

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.