Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00491725

AGEE-1655

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

Enrollment: 187 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 12 weeks
• HbA1c: 8.0-10.0%
• Current treatment with OAD on monotheray or OAD on combination therapy
• Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products
• Recurrent major hypoglycaemia as judged by the Investigator
• Uncontrolled hypertension
• Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)