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

March 5, 2021 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Rijeka, Croatia, 51 000
        • Novo Nordisk Investigational Site
      • Varazdin, Croatia, 42 000
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45136
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Oldenburg I. Holst, Germany, 23758
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
  • Hungary
      • Kaposvár, Hungary, 7400
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6725
        • Novo Nordisk Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-435
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Radom, Poland, 26-600
        • Novo Nordisk Investigational Site
      • Tomaszow Mazowiecki, Poland, 97-200
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 01
        • Novo Nordisk Investigational Site
      • Nitra, Slovakia, 94911
        • Novo Nordisk Investigational Site
      • Rimavska Sobota, Slovakia, 97901
        • Novo Nordisk Investigational Site
      • Roznava, Slovakia, 04801
        • Novo Nordisk Investigational Site
      • Velky Meder, Slovakia, 93201
        • Novo Nordisk Investigational Site
  • Spain
      • Baracaldo, Spain, 48903
        • Novo Nordisk Investigational Site
      • La Coruña, Spain, 15006
        • Novo Nordisk Investigational Site
      • La Roca del Vallés, Spain, 08430
        • Novo Nordisk Investigational Site
      • Vic (Barcelona), Spain, 08500
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
      • Statesboro, Georgia, United States, 30461
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
    • New York
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Schertz, Texas, United States, 78154
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Insulin icodec
Administered subcutaneously SC once weekly. Starting dose will be 70U.
Other Names:
  • Insulin 287
Experimental: Insulin 287 algorithm B
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin icodec
Administered subcutaneously SC once weekly. Starting dose will be 70U.
Other Names:
  • Insulin 287
Experimental: Insulin 287 algorithm C
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin icodec
Administered subcutaneously SC once weekly. Starting dose will be 70U.
Other Names:
  • Insulin 287
Active Comparator: Insulin Glargine algorithm D
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin Glargine
Administered subcutaneously SC once daily.The starting dose will be 10U.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the last 2 weeks of treatment (week 15 and 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycated Haemoglobin)
Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18)
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).
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)
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).
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)
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).
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)
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).
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)
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.
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)
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.
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)
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.
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)
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.
From baseline week 0 (visit 2) to week 16 (visit 18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2019

Primary Completion (Actual)

December 12, 2019

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4465
  • U1111-1219-5474 (Other Identifier: World Health Organization (WHO))
  • 2018-003406-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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