A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

Novo Nordisk A/S412 enrolled

Overview

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

412

Conditions

Diabetes, Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening. * HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis. * Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products. * Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2). Exclusion Criteria: * Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening. * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * Chronic heart failure classified as being in New York Heart Association Class IV at screening. * Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids). * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Locations (83)

Valley Research

Fresno, California, United States

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Headlands Research CTR Lincoln

Lincoln, California, United States

Northeast Research Institute of Florida

Fleming Island, Florida, United States

Outcomes

Primary Outcomes

Change in Glycated Haemoglobin (HbA1c)

Change in HbA1c from week 0 to week 26 in percentage point is presented.

Time frame: Week 0, Week 26

Secondary Outcomes

Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))

Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.

Time frame: week -4-0, week 22-26

Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction

Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

Time frame: week 0 to week 26

Number of Severe Hypoglycaemic Episodes (Level 3)

Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

Time frame: From baseline (week 0) to week 31

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented.

Time frame: From baseline (week 0) to week 31

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

Time frame: From baseline (week 0) to week 31

Time Spent < 3.0 mmol/L (54 mg/dL)

Time spent \< 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.

Time frame: Week 22-26

Change in Time Spent > 10.0 mmol/L (180 mg/dL)

Change in time spent \> 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.

Time frame: Week -4-0, Week 22-26

Mean Weekly Insulin Dose

Mean weekly insulin dose from week 24 to week 26 is presented.

Time frame: From week 24 to week 26

Change in Body Weight

Change in body weight from baseline (week 0) to (week 26) is presented.

Time frame: Week 0, Week 26