NCT03951805|CompletedPhase 2ResultsFDA Drug

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

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 Insulin-naïve Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1436-4465U1111-1219-54742018-003406-11

Study Type

interventional

Target

205

Locations

7 countries

Sites

Timeline

RegisteredMay 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 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

205

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

7 countries

43 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

8 months study duration

Study Start

First participant enrolled

May 9, 2019

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed

12 months until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed

Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

May 10, 2019

Results QC Date

December 11, 2020

Last Update Submit

March 5, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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)
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 considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). The endpoint is based on data recorded by CGM system. It was required that at least 70% of the planned CGM measurements during weeks 15-16 were available for endpoint data to be included in the analysis.
During the last 2 weeks of treatment (week 15 and 16)

Secondary Outcomes (8)

Change in HbA1c (Glycated Haemoglobin)
From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Fasting Plasma Glucose (FPG)
From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Body Weight
From baseline week 0 (visit 2) to week 16 (visit 18)
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 (visit 2) to week 21 (visit 20)
+3 more secondary outcomes

Study Arms (4)

Insulin 287 algorithm A

EXPERIMENTAL

Controlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).

Drug: Insulin icodec

Insulin 287 algorithm B

EXPERIMENTAL

Controlled on metformin with or without DPP4i and with or without SGLT2i.

Drug: Insulin icodec

Insulin 287 algorithm C

EXPERIMENTAL

Controlled on metformin with or without DPP4i and with or without SGLT2i.

Drug: Insulin icodec

Insulin Glargine algorithm D

ACTIVE COMPARATOR

Controlled on metformin with or without DPP4i and with or without SGLT2i.

Drug: Insulin Glargine

Interventions

Insulin icodecDRUG

Administered subcutaneously SC once weekly. Starting dose will be 70U.

Also known as: Insulin 287

Insulin 287 algorithm AInsulin 287 algorithm BInsulin 287 algorithm C

Insulin GlargineDRUG

Administered subcutaneously SC once daily.The starting dose will be 10U.

Insulin Glargine algorithm D

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 7.0-10.0% (53.0-85.8 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 records)
Free or fixed combination therapy: Metformin as outlined above plus/minus DPP4i with or without SGLT2i is allowed:
i) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose) ii) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose )
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) below or equal to 40.0 kg/m\^2

Contact the study team to confirm eligibility.