Comparison of NN5401 versus insulin glargine, both with metformin treatment, in subjects with type 2 diabetes

A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOSTâ?¢ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes - (BOOSTâ?¢: START 1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000044

Enrollment

526

Registered

2010-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Diabetes Mellitus, Type 2

Interventions

Intervention1: NN5401: NN5401 injected s.c. (under the skin) once daily with the breakfast meal. Dose will be individually adjusted Control Intervention1: Insulin Glargine.: Insulin glargine injected

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of type 2 diabetes mellitus for at least 6 months Insulin naÃ¯ve subjects Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start HbA1c between 7.5 ? 11.0% (both inclusive) BMI (Body Mass Index) no higher than 40.0 kg/m2 Age 18 and older

Exclusion criteria

Exclusion criteria: Treatment with GLP-1 receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start Cardiovascular disease diagnosed within 6 months before trial start

Design outcomes

Primary

Measure	Time frame
HbA1c changeTimepoint: From baseline after 26 weeks of treatment	—

Secondary

Measure	Time frame
Plasma glucose profilesTimepoint: After 26 weeks of treatment	—

Countries

India

Contacts

Public ContactMr Avik Kumar Ghosh

Novo Nordisk India Private Limited.

rasy@novonordisk.com918041123518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026