Comparison of NN1250 with insulin glargine in type 2 diabetes

A 26 week randomised, controlled, open label, multicentre, multinational, three-arm, treat to target trial comparing efficacy and safety of three different dosing regimens of either NN1250 or insulin glargine with or without combination with OAD treatment, in subjects with type 2 diabetes mellitus (BEGIN? : FLEX)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000804

Enrollment

687

Registered

2010-06-04

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: NN1250: NN1250 injected s.c. (under the skin) once daily. The doses will be individually adjusted Intervention2: NN1250: NN1250 injected s.c. (under the skin) once daily (alternative r

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus for at least 6 months Currently treated with oral antidiabetic drugs, treated with insulin or a combination of oral antidiabetic drugs and insulin for at least 3 months For patients currently treated with oral antidiabetic drug: HbA1c 7-11% For patients currently treated with insulin: HbA1c 7-10% Body Mass Index (BMI) below or equal to 40.0 kg/m2 Age 18 years and older

Exclusion criteria

Exclusion criteria: Use GLP-1 receptor agonist (exenatide, liraglutide), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors within the last 3 months prior to trial start Cardiovascular disease, within the last 6 months Uncontrolled treated/untreated severe hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures Cancer and medical history of cancer hereof

Design outcomes

Primary

Measure	Time frame
HbA1c change from baselineTimepoint: from baseline	—

Secondary

Measure	Time frame
Hypoglycaemic episodes, plasma glucose profilesTimepoint: 26 Weeks	—

Countries

India

Contacts

Public ContactMr Avik Kumar Ghosh

Novo Nordisk India Private Ltd.

rasy@novonordisk.com918030713358

Outcome results

None listed

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