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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03951805
Other study ID # NN1436-4465
Secondary ID U1111-1219-54742
Status Completed
Phase Phase 2
First received
Last updated
Start date May 9, 2019
Est. completion date January 17, 2020

Study information

Verified date March 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date January 17, 2020
Est. primary completion date December 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Insulin icodec
Administered subcutaneously SC once weekly. Starting dose will be 70U.
Insulin Glargine
Administered subcutaneously SC once daily.The starting dose will be 10U.

Locations

Country Name City State
Croatia Novo Nordisk Investigational Site Karlovac
Croatia Novo Nordisk Investigational Site Osijek
Croatia Novo Nordisk Investigational Site Rijeka
Croatia Novo Nordisk Investigational Site Varazdin
Germany Novo Nordisk Investigational Site Bad Mergentheim
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Falkensee
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Münster
Germany Novo Nordisk Investigational Site Oldenburg I. Holst
Germany Novo Nordisk Investigational Site Pohlheim
Germany Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach
Hungary Novo Nordisk Investigational Site Kaposvár
Hungary Novo Nordisk Investigational Site Szeged
Hungary Novo Nordisk Investigational Site Zalaegerszeg
Poland Novo Nordisk Investigational Site Bialystok
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Radom
Poland Novo Nordisk Investigational Site Tomaszow Mazowiecki
Poland Novo Nordisk Investigational Site Warszawa
Slovakia Novo Nordisk Investigational Site Banska Bystrica
Slovakia Novo Nordisk Investigational Site Kosice
Slovakia Novo Nordisk Investigational Site Nitra
Slovakia Novo Nordisk Investigational Site Rimavska Sobota
Slovakia Novo Nordisk Investigational Site Roznava
Slovakia Novo Nordisk Investigational Site Velky Meder
Spain Novo Nordisk Investigational Site Baracaldo
Spain Novo Nordisk Investigational Site La Coruña
Spain Novo Nordisk Investigational Site La Roca del Vallés
Spain Novo Nordisk Investigational Site Vic (Barcelona)
United States Novo Nordisk Investigational Site Anaheim California
United States Novo Nordisk Investigational Site Austin Texas
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Lancaster California
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site Schertz Texas
United States Novo Nordisk Investigational Site Statesboro Georgia
United States Novo Nordisk Investigational Site West Seneca New York

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Croatia,  Germany,  Hungary,  Poland,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During the last 2 weeks of treatment (week 15 and 16)
Secondary 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). From baseline week 0 (visit 2) to week 16 (visit 18)
Secondary 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). From baseline week 0 (visit 2) to week 16 (visit 18)
Secondary 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). From baseline week 0 (visit 2) to week 16 (visit 18)
Secondary 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). During the last 2 weeks of treatment (week 15 and 16)
Secondary 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. From baseline week 0 (visit 2) to week 21 (visit 20)
Secondary 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. From baseline week 0 (visit 2) to week 16 (visit 18)
Secondary 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. From baseline week 0 (visit 2) to week 16 (visit 18)
Secondary 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. From baseline week 0 (visit 2) to week 16 (visit 18)
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