A 78-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with non-insulin anti-diabetic treatment, in insulin naive subjects with type 2 diabetes.(NN1436-4477)

JRCT ID: jRCT2031200241

Registered date:14/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 03/12/2020
• Target sample size: 155
• Countries of recruitment: Croatia,Japan,India,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Russia,Japan,Slovakia,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Two arm for insulin icodec and insulin glargine
The study will consist of 3 periods: a Screening Period, a Treatment Period, and a Follow-Up Period.

Outcome(s)

• Primary Outcome: The objective of this trial is to demonstrate the effect on glycaemic control of once weekly insulin icodec, in combination with non-insulin anti-diabetic drugs, in insulin naive subjects with T2D. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine after 52 weeks of treatment to a non-inferiority limit of 0.3%.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male or female aged above or equal to 18 years at the time of signing informed consent.
2. Diagnosed with T2D >= 180 days prior to the day of screening.
3. HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
4. Insulin naive. 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.
5. Stable daily dose(s) >= 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations >= 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations >= 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ( >= half of the maximum approved dose according to local label or maximum tolerated or effective dose):
- Sulfonylureas
- Meglitinides (glinides)
- DPP-4 inhibitors
- SGLT2 inhibitors
- Thiazolidinediones
- Alpha-glucosidase inhibitors
- Oral combination products (for the allowed individual oral anti-diabetic drugs)
-Oral or injectable GLP-1 receptor agonists
6. Body mass index (BMI) <=40.0 kg/m2.

Exclude criteria

1. Any episodesa of diabetic ketoacidosis within 90 days prior to the day of screening.
2. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
3. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
4. 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).
5. 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.

Related Information

• Primary Sponsor: Nishiba Hiroko
• Secondary ID(s): NCT04460885,2020-000442-34