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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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ClinicalTrials.gov Identifier: NCT03922750
Recruitment Status : Completed
First Posted : April 22, 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 switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The 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 doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin icodec Drug: Insulin glargine U100 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 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 Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : May 9, 2019
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : January 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin 287 (with 100% loading dose)
Participants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used.
Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
Other Name: Insulin 287

Experimental: Insulin 287 (without loading dose)
Participants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used.
Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
Other Name: Insulin 287

Active Comparator: Insulin glargine U100
Participants will receive insulin glargine U100 once daily (OD).
Drug: Insulin glargine U100
Participants will receive s.c. injections of insulin glargine OD for 16 weeks




Primary Outcome Measures :
  1. Percentage of Time in Target Range 3.9-10.0 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 on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).


Secondary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Estimated mean change from baseline (week 0) in HbA1c at week 16 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 on treatment with 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 (V2) to week 16 (V18) ]
    Estimated mean change from baseline (week 0) in FPG at week 16 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 on treatment with 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 (V2) to week 16 (V18) ]
    Estimated mean change from baseline (week 0) in body weight at week 16 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 on treatment with 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 on treatment with 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 (V2) to week 21 (V20) ]
    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 on-treatment observation period was the time period from 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. Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.

  6. Number of Severe Hypoglycaemic Episodes (Level 3) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    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 during weeks 0-16 are presented.

  7. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    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 <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 during weeks 0-16 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 BG Meter) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    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. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter) that occured during weeks 0-16 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.
  • Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
  • Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
  • 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 with or without dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose.
  • Body mass index (BMI) less than or equal to 40.0 kg/m^2.

Exclusion criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
  • Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
  • Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
  • 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.

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): NCT03922750


Locations
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United States, California
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Georgia
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
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
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
Canada, Alberta
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T6G 2E1
Canada, British Columbia
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3Z 2N6
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V5Y 3W2
Canada, Nova Scotia
Novo Nordisk Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novo Nordisk Investigational Site
Brampton, Ontario, Canada, L6S 0C6
Novo Nordisk Investigational Site
Concord, Ontario, Canada, L4K 4M2
Novo Nordisk Investigational Site
Etobicoke, Ontario, Canada, M9R 4E1
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site
Markham, Ontario, Canada, L3P 7P2
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Czechia
Novo Nordisk Investigational Site
Broumov, Czechia, 550 01
Novo Nordisk Investigational Site
Holešov, Czechia, 76901
Novo Nordisk Investigational Site
Hranice, Czechia, 75301
Novo Nordisk Investigational Site
Trutnov, Czechia, 541 01
Germany
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Oldenburg I. Holst, Germany, 23758
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, Germany, 66386
Italy
Novo Nordisk Investigational Site
Bergamo, Italy, 24127
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Milano, Italy, 20122
Novo Nordisk Investigational Site
Milano, Italy, 20132
Novo Nordisk Investigational Site
Roma, Italy, 00161
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] May 28, 2020
Statistical Analysis Plan  [PDF] May 28, 2020

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03922750    
Other Study ID Numbers: NN1436-4466
U1111-1219-5541 ( Other Identifier: World Health Organization (WHO) )
2018-003407-18 ( EudraCT Number )
First Posted: April 22, 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