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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

NCT ID: NCT03951805

Last Updated: 2021-04-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2020-01-17

Brief Summary

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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.

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

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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.

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Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

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A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

NCT04460885

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A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

NCT03723772

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin 287 algorithm A

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

Group Type EXPERIMENTAL

Insulin icodec

Intervention Type DRUG

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

Insulin 287 algorithm B

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

Group Type EXPERIMENTAL

Insulin icodec

Intervention Type DRUG

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

Insulin 287 algorithm C

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

Group Type EXPERIMENTAL

Insulin icodec

Intervention Type DRUG

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

Insulin Glargine algorithm D

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

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

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

Interventions

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Insulin icodec

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

Intervention Type DRUG

Insulin Glargine

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

Intervention Type DRUG

Other Intervention Names

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Insulin 287

Eligibility Criteria

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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 7.0-10.0% (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):

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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Anaheim, California, United States

Site Status

Novo Nordisk Investigational Site

Lancaster, California, United States

Site Status

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Statesboro, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Site Status

Novo Nordisk Investigational Site

West Seneca, New York, United States

Site Status

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Austin, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Schertz, Texas, United States

Site Status

Novo Nordisk Investigational Site

Karlovac, , Croatia

Site Status

Novo Nordisk Investigational Site

Osijek, , Croatia

Site Status

Novo Nordisk Investigational Site

Rijeka, , Croatia

Site Status

Novo Nordisk Investigational Site

Varaždin, , Croatia

Site Status

Novo Nordisk Investigational Site

Bad Mergentheim, , Germany

Site Status

Novo Nordisk Investigational Site

Essen, , Germany

Site Status

Novo Nordisk Investigational Site

Falkensee, , Germany

Site Status

Novo Nordisk Investigational Site

Friedrichsthal, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Münster, , Germany

Site Status

Novo Nordisk Investigational Site

Oldenburg I. Holst, , Germany

Site Status

Novo Nordisk Investigational Site

Pohlheim, , Germany

Site Status

Novo Nordisk Investigational Site

Saint Ingbert-Oberwürzbach, , Germany

Site Status

Novo Nordisk Investigational Site

Kaposvár, , Hungary

Site Status

Novo Nordisk Investigational Site

Szeged, , Hungary

Site Status

Novo Nordisk Investigational Site

Zalaegerszeg, , Hungary

Site Status

Novo Nordisk Investigational Site

Bialystok, , Poland

Site Status

Novo Nordisk Investigational Site

Lublin, , Poland

Site Status

Novo Nordisk Investigational Site

Radom, , Poland

Site Status

Novo Nordisk Investigational Site

Tomaszów Mazowiecki, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Banská Bystrica, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Nitra, , Slovakia

Site Status

Novo Nordisk Investigational Site

Rimavská Sobota, , Slovakia

Site Status

Novo Nordisk Investigational Site

Rožňava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Veľký Meder, , Slovakia

Site Status

Novo Nordisk Investigational Site

A Coruña, , Spain

Site Status

Novo Nordisk Investigational Site

Barakaldo, , Spain

Site Status

Novo Nordisk Investigational Site

La Roca Del Vallés, , Spain

Site Status

Novo Nordisk Investigational Site

Vic (Barcelona), , Spain

Site Status

Countries

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United States Croatia Germany Hungary Poland Slovakia Spain

References

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Lingvay I, Buse JB, Franek E, Hansen MV, Koefoed MM, Mathieu C, Pettus J, Stachlewska K, Rosenstock J. A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100. Diabetes Care. 2021 Jul;44(7):1595-1603. doi: 10.2337/dc20-2878. Epub 2021 Apr 19.

Reference Type DERIVED
PMID: 33875484 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1219-5474

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003406-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1436-4465

Identifier Type: -

Identifier Source: org_study_id

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