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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

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ClinicalTrials.gov Identifier: NCT03951805
Recruitment Status : Completed
First Posted : May 15, 2019
Results First Posted : January 8, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin icodec Drug: Insulin Glargine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2019
Actual Primary Completion Date : December 12, 2019
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  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) [ 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 7.0-10.0% (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951805


Locations
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United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Lancaster, California, United States, 93534
United States, Georgia
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
Novo Nordisk Investigational Site
Statesboro, Georgia, United States, 30461
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New York
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Schertz, Texas, United States, 78154
Croatia
Novo Nordisk Investigational Site
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
Germany
Novo Nordisk Investigational Site
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
Hungary
Novo Nordisk Investigational Site
Kaposvár, Hungary, 7400
Novo Nordisk Investigational Site
Szeged, Hungary, H-6725
Novo Nordisk Investigational Site
Zalaegerszeg, Hungary, 8900
Poland
Novo Nordisk Investigational Site
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
Slovakia
Novo Nordisk Investigational Site
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
Spain
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] April 14, 2020
Statistical Analysis Plan  [PDF] April 14, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03951805    
Other Study ID Numbers: NN1436-4465
U1111-1219-5474 ( Other Identifier: World Health Organization (WHO) )
2018-003406-11 ( EudraCT Number )
First Posted: May 15, 2019    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs