A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen. ONWARDS 4.

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2021/06/034231
• Lead Sponsor: Novo Nordisk Denmark

Brief Summary

This is a 26-week randomised, open label, active-controlled, parallel-group, multicentre, multinational, treat-to-target trial with two treatment arms investigating the effect on glycaemic control and safety of treatment with once weekly insulin icodec compared to once daily insulin glargine, both in combination with insulin aspart with or without non-insulin anti-diabetic drugs, in subjects with T2D.The trial duration is approximately 33 weeks, consisting of a 2-week screening period, followed by a 26-week randomised treatment period and a 5-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

• Informed consent obtained before any trial-related activities.
• Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• Diagnosed with T2D ≥ 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 basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, faster acting insulin lispro, insulin glulisine) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses ≥ 90 days prior to screening: • Metformin • 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 RAs 7.
• Body mass index (BMI) ≤ 40.0 kg/m2.

Exclusion Criteria

• Subjects are excluded from the trial if any of the following criteria apply: 1.
• Known or suspected hypersensitivity to trial product(s) or related products.
• Previous participation in this trial.
• Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screeninga.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with	Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus	Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
VV-	Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
regimen. This includes comparing the difference in change from baseline in HbA1c between insulin	Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.	Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point

Secondary Outcome Measures

Name	Time	Method
Number of severe hypoglycaemic	episodes (level 3)
Change in fasting plasma glucose	(FPG)
Time in target-range 3.9–10.0	mmol/L (70-180 mg/dL)
Number of clinically significant	hypoglycaemic episodes (level 2)

Trial Locations

Locations (12)

Prince Aly Khan Hospital,; 🇮🇳 Mumbai, MAHARASHTRA, India

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Bangalore Diabetes Centre; 🇮🇳 Bangalore, KARNATAKA, India

BSES Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

DTEC-Diabetes, Thyroid and Endocrine Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Lifecare Hospital and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Manipal Hospital Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Max Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Medanta The Medicity, Gurgaon; 🇮🇳 Gurgaon, HARYANA, India

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Prince Aly Khan Hospital,

🇮🇳Mumbai, MAHARASHTRA, India

Dr Shehla Shaikh

Principal investigator

9820984842

drshehla@rediffmail.com