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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: isophane human insulin; Drug: insulin; Drug: repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720303

AGEE-3020

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Enrollment: 159 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c between 7.5 % and 13.0% (both inclusive)
• Fasting C-peptide above or equal to 0.33 nmol/l
• BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion criteria

• Medical history of treatment with insulin within the last 6 months
• Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Rep + NPH

Experimental group

Treatment:

Drug: isophane human insulin

Drug: repaglinide

Premixed insulin/NPH

Active Comparator group

Treatment:

Drug: insulin