Diabetes Mellitus, Type 2Phase 2NCT03951805

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 Phase 2 study testing Insulin icodec and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 43 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin icodec and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 43 sitesin 7 countries
Study dates: 9 May 2019to 17 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

43 sites in 7 countries.

Country

City, postcode or hospital

43 sites in 7 countries

United States12 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Schertz, Texas, 78154
Novo Nordisk Investigational Site
Statesboro, Georgia, 30461
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

Germany9 sites

Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Essen, 45136
Novo Nordisk Investigational Site
Falkensee, 14612
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Oldenburg I. Holst, 23758
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Slovakia6 sites

Novo Nordisk Investigational Site
Banská Bystrica, 97401
Novo Nordisk Investigational Site
Košice, 040 01
Novo Nordisk Investigational Site
Nitra, 94911
Novo Nordisk Investigational Site
Rimavská Sobota, 97901
Novo Nordisk Investigational Site
Rožňava, 04801
Novo Nordisk Investigational Site
Veľký Meder, 93201

Other trials in Slovakia

Poland5 sites

Novo Nordisk Investigational Site
Bialystok, 15-435
Novo Nordisk Investigational Site
Lublin, 20-538
Novo Nordisk Investigational Site
Radom, 26-600
Novo Nordisk Investigational Site
Tomaszów Mazowiecki, 97-200
Novo Nordisk Investigational Site
Warsaw, 02-507

Other trials in Poland

Croatia4 sites

Novo Nordisk Investigational Site
Karlovac, 47000
Novo Nordisk Investigational Site
Osijek, 31 000
Novo Nordisk Investigational Site
Rijeka, 51 000
Novo Nordisk Investigational Site
Varaždin, 42 000

Other trials in Croatia

Spain4 sites

Novo Nordisk Investigational Site
A Coruña, 15006
Novo Nordisk Investigational Site
Barakaldo, 48903
Novo Nordisk Investigational Site
La Roca Del Vallés, 08430
Novo Nordisk Investigational Site
Vic (Barcelona), 08500

Other trials in Spain

Hungary3 sites

Novo Nordisk Investigational Site
Kaposvár, 7400
Novo Nordisk Investigational Site
Szeged, H-6725
Novo Nordisk Investigational Site
Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: 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

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin icodec, Insulin Glargine
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin icodecDrug
Also called Insulin 287
Administered subcutaneously SC once weekly. Starting dose will be 70U.
Insulin GlargineDrug
Administered subcutaneously SC once daily.The starting dose will be 10U.

Study groups in NCT03951805
Study group	Role	What they receive
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). Receives: Drug: Insulin icodec
Insulin 287 algorithm B	Experimental	Controlled on metformin with or without DPP4i and with or without SGLT2i. Receives: Drug: Insulin icodec
Insulin 287 algorithm C	Experimental	Controlled on metformin with or without DPP4i and with or without SGLT2i. Receives: Drug: Insulin icodec
Insulin Glargine algorithm D	Active comparator	Controlled on metformin with or without DPP4i and with or without SGLT2i. Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During the last 2 weeks of treatment (week 15 and 16)

Secondary outcomes (8)

Change in HbA1c (Glycated Haemoglobin)
Estimated mean change in HbA1c from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. 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).
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Fasting Plasma Glucose (FPG)
Estimated mean change in FPG from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. 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).
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Body Weight
Estimated mean change in body weight from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. 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).
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)
Weekly Insulin Dose
Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. 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).
Measured: During the last 2 weeks of treatment (week 15 and 16)
Number of Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product (week 0, visit 2) until the follow-up visit (week 21, visit 20) or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin.
Measured: From baseline week 0 (visit 2) to week 21 (visit 20)
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 baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (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 occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)
Number of Hypoglycaemic Alert Episodes (Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by Blood Glucose (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 < 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
Measured: From baseline week 0 (visit 2) to week 16 (visit 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201917 Jan 2020

First posted15 May 2019
Study start9 May 2019
Primary completion12 Dec 2019
Study completion17 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03951805
Sponsor's protocol ID: NN1436-4465
Other IDs: U1111-1219-5474, 2018-003406-11, 2018
Status last verified: Mar 2021
First submitted: 10 May 2019
Last updated: 5 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

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.
PubMed 33875484

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03951805
Acronym / sponsor ID: NN1436-4465
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 9 May 2019 (actual)
Primary completion: 12 Dec 2019 (actual)
Study completion: 17 Jan 2020 (actual)
First posted: 15 May 2019 (actual)
Results: Posted 8 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Insulin 287 algorithm A	Experimental	Drug: Insulin icodecControlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).
Insulin 287 algorithm B	Experimental	Drug: Insulin icodecControlled on metformin with or without DPP4i and with or without SGLT2i.
Insulin 287 algorithm C	Experimental	Drug: Insulin icodecControlled on metformin with or without DPP4i and with or without SGLT2i.
Insulin Glargine algorithm D	Active comparator	Drug: Insulin GlargineControlled on metformin with or without DPP4i and with or without SGLT2i.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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):
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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin icodecAlso: Insulin 287Administered subcutaneously SC once weekly. Starting dose will be 70U.	Drug	Insulin 287 algorithm A, Insulin 287 algorithm B, Insulin 287 algorithm C
Insulin GlargineAdministered subcutaneously SC once daily.The starting dose will be 10U.	Drug	Insulin Glargine algorithm D

Primary outcome

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)
Time frame: During the last 2 weeks of treatment (week 15 and 16)
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.

8 secondary outcomes

Change in HbA1c (Glycated Haemoglobin)
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)
Change in Body Weight
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)
Weekly Insulin Dose
Time frame: During the last 2 weeks of treatment (week 15 and 16)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline week 0 (visit 2) to week 21 (visit 20)
Number of Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)
Number of Hypoglycaemic Alert Episodes (Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by Blood Glucose (BG) Meter)
Time frame: From baseline week 0 (visit 2) to week 16 (visit 18)

Results and safety

Results posted to the registry on 8 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin 287 (Titration Algorithm A)	51	50
Insulin 287 (Titration Algorithm B)	51	51
Insulin 287 (Titration Algorithm C)	52	52
Insulin Glargine (Titration Algorithm D)	51	51

Primary outcome: 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)

Time frame: During the last 2 weeks of treatment (week 15 and 16). Least squares mean (Standard Error). Unit: Percentage of time

Measure	Insulin 287 (Titration Algorithm A) n = 51	Insulin 287 (Titration Algorithm B) n = 51	Insulin 287 (Titration Algorithm C) n = 51	Insulin Glargine (Titration Algorithm D) n = 50
Value	76.65 (1.81)	82.97 (1.80)	80.89 (1.81)	75.89 (1.82)

Insulin 287 (Titration Algorithm A) vs Insulin Glargine (Titration Algorithm D): Treatment difference: 0.76 (95% CI -4.28 to 5.80), p = 0.7675, ANCOVA
Insulin 287 (Titration Algorithm B) vs Insulin Glargine (Titration Algorithm D): Treatment difference: 7.08 (95% CI 2.12 to 12.04), p = 0.0051, ANCOVA
Insulin 287 (Titration Algorithm C) vs Insulin Glargine (Titration Algorithm D): Treatment difference: 5.01 (95% CI -0.04 to 10.05), p = 0.0519, ANCOVA

Population analysed: Full analysis set included all randomised participants. Overall number of participants analyzed = Number of participants who contributed to the analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (week 0) to week 21 Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin 287 (Titration Algorithm A)	3 of 51 (5.9%)	9 of 51 (17.6%)	0 of 51
Insulin 287 (Titration Algorithm B)	1 of 51 (2%)	10 of 51 (19.6%)	0 of 51
Insulin 287 (Titration Algorithm C)	0 of 52 (0%)	7 of 52 (13.5%)	0 of 52
Insulin Glargine (Titration Algorithm D)	2 of 51 (3.9%)	9 of 51 (17.6%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33875484Lingvay 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.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

43 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin icodec and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Germany, Slovakia, Poland, Croatia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: During the last 2 weeks of treatment (week 15 and 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03951805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.