Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562561

AGEE-1272

Details and patient eligibility

About

This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 2 diabetes
• HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
• BMI (body mass index) maximum 35 kg/m^2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

213 participants in 2 patient groups

Rep + NPH

Experimental group

Treatment:

Drug: insulin NPH

Drug: repaglinide

NPH

Active Comparator group

Treatment:

Drug: insulin NPH