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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.

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Insulin icodec

Placebo (insulin 287)

Metformin

Dipeptidyl peptidase-4 inhibitors

Insulin glargine

Placebo (insulin glargine)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. 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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin 287

Insulin glargine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Change in HbA1c [Millimoles/Mole (mmol/Mol)]

Secondary Outcome Measures

Change in Fasting Plasma Glucose

Change in fasting plasma glucose 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.

9-point Profile (Individual SMPG Values)

Participants measured their plasma glucose (PG) levels using blood glucose meters (as plasma equivalent values of capillary whole blood glucose) at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values after 26 weeks are 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.

Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 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.

Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).

Participants measured their plasma glucose (PG) levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Presented fluctuation in 9-point SMPG profile is the integrated absolute distance from the mean profile value divided by measurement time and is calculated using the trapezoidal method. 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.

Fasting C-peptide

Fasting C-peptide at 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.

Change in Body Weight

Change in body weight 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.

Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine

Weekly dose of insulin 287 and weekly dose of glargine at week 25 and week 26 are 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.

Number of Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The endpoint was evaluated based on the data from on-treatment period, starting at the date of first dose of trial product, and ending at follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin.

Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <70 mg/dL), Confirmed by BG Meter)

Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occurred from week 0 to week 26 are presented.

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 26 are presented.

Number of Severe Hypoglycaemic Episodes (Level 3)

Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from week 0 to week 26 are presented.

Change in Anti-insulin 287 Antibody Titres

Samples from the insulin 287 arm of the study were analysed for anti-insulin 287 antibodies. Confirmed anti-insulin 287 antibody positive samples had an antibody titre value determined. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death.

Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative)

Anti-insulin 287 or glargine antibodies were classified as negative if % B/T was below a certain cut point. Samples positive for anti-insulin 287 or glargine antibodies were further tested for cross-reactivity to endogenous insulin. Samples not further tested are categorised as not applicable (NA). Unknown refers to samples with insufficient volume to perform analysis. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death.

Change in Anti-insulin 287 Antibody Level

Change in anti-insulin 287 antibodies level is not assessed because change in anti-insulin 287 antibody titres is a more meaningful way of describing the change in antibody levels. The results for change in anti-insulin 287 antibody titres are reported as a separate endpoint.

Full Information

NCT ID

NCT03751657

First Posted

November 16, 2018

Last Updated

March 5, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03751657

Brief Title

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.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 29, 2018 (Actual)

Primary Completion Date

December 16, 2019 (Actual)

Study Completion Date

January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Allocation

Randomized

Enrollment

247 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin 287

Arm Type

Experimental

Arm Description

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.

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Insulin icodec

Other Intervention Name(s)

Insulin 287

Intervention Description

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

Intervention Name(s)

Placebo (insulin 287)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dipeptidyl peptidase-4 inhibitors

Intervention Description

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

Intervention Name(s)

Insulin glargine

Intervention Description

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

Intervention Name(s)

Placebo (insulin glargine)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)]

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Change in HbA1c [Millimoles/Mole (mmol/Mol)]

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Secondary Outcome Measure Information:

Title

Change in Fasting Plasma Glucose

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

9-point Profile (Individual SMPG Values)

Description

Time Frame

Week 26 (Visit 28)

Title

Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time).

Description

Time Frame

Week 26 (Visit 28)

Title

Fasting C-peptide

Description

Time Frame

At week 26 (Visit 28)

Title

Change in Body Weight

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine

Description

Time Frame

week 25 (Visit 27) and 26 (Visit 28)

Title

Number of Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

From baseline (Visit 2) to week 31 (Visit 30)

Title

Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <70 mg/dL), Confirmed by BG Meter)

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Number of Severe Hypoglycaemic Episodes (Level 3)

Description

Time Frame

From baseline (Visit 2) to week 26 (Visit 28)

Title

Change in Anti-insulin 287 Antibody Titres

Description

Time Frame

From baseline (Visit 2) to week 31 (Visit 30)

Title

Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative)

Description

Time Frame

From baseline (Visit 2) to week 31 (Visit 30)

Title

Change in Anti-insulin 287 Antibody Level

Description

Time Frame

From baseline (Visit 2) to week 31 (Visit 30)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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 Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Whiteville

State/Province

North Carolina

ZIP/Postal Code

28472

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9302

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6S 0C6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Concord

State/Province

Ontario

ZIP/Postal Code

L4K 4M2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9R 4E1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

St-Marc-des-Carrières

State/Province

Quebec

ZIP/Postal Code

G0A 4B0

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

62500

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 1

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

149 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 5

ZIP/Postal Code

150 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 8

ZIP/Postal Code

181 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Rakovník

ZIP/Postal Code

269 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Slaný

ZIP/Postal Code

27401

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54636

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57010

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-404

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lodz

ZIP/Postal Code

90-132

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

61-251

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warsaw

ZIP/Postal Code

00-465

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wierzchoslawice

ZIP/Postal Code

33-122

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

821 02

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Moldava nad Bodvou

ZIP/Postal Code

045 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Sahy

ZIP/Postal Code

93601

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Trencin

ZIP/Postal Code

91101

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Koper

ZIP/Postal Code

SI-6000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Ljubljana

ZIP/Postal Code

SI-1000

Country

Slovenia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Citations:

Citation

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

Results Reference

result

PubMed Identifier

32960514

Citation

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.

Results Reference

derived

Learn more about this trial

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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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.

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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