Clinical trial NCT03922750: A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: During the last 2 weeks of treatment (week 15 and 16)
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: From baseline week 0 (V2) to week 16 (V18)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline week 0 (V2) to week 16 (V18)
measure: Change in Body Weight
timeFrame: From baseline week 0 (V2) to week 16 (V18)
measure: Weekly Insulin Dose
timeFrame: During the last 2 weeks of treatment (week 15 and 16)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline week 0 (V2) to week 21 (V20)
measure: Number of Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline week 0 (V2) to week 16 (V18)
measure: 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)
timeFrame: From baseline week 0 (V2) to week 16 (V18)
measure: 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)
timeFrame: From baseline week 0 (V2) to week 16 (V18)
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Nashua
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Concord
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Broumov
country: Czechia
facility: Novo Nordisk Investigational Site
city: Holešov
country: Czechia
facility: Novo Nordisk Investigational Site
city: Hranice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Trutnov
country: Czechia
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Oldenburg I. Holst
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Bajaj HS, Bergenstal RM, Christoffersen A, Davies MJ, Gowda A, Isendahl J, Lingvay I, Senior PA, Silver RJ, Trevisan R, Rosenstock J. Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial. Diabetes Care. 2021 Jul;44(7):1586-1594. doi: 10.2337/dc20-2877. Epub 2021 Apr 19.