Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: repaglinide; metformin; repaglinide
Intervention description: The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily; The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily; The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.
Intervention MeSH terms: Metformin; Repaglinide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 433.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect of repaglinide plus metformin as initial treatment compared to
      repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated
      haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The
      associated unfavourable events including low blood sugar episodes between the two treatments
      are also compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Never taken oral antidiabetic drugs before

          -  HbA1c greater than 8.5 %

          -  BMI (Body Mass Index) less than or equal to 35 kg/m^2

        Exclusion Criteria:

          -  Known or suspected allergy to repaglinide, metformin, or any of the excipients in the
             medications

          -  Taken an investigational drug in another clinical trial within 4 weeks prior to this
             trial

          -  Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine
             aminotransferase) equal to or greater than 2 times upper normal limit

          -  Have a clinically significant, active disease of the gastrointestinal, pulmonary,
             neurological, renal, genitourinary, and haematological systems

          -  Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP)
             equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)

          -  Impaired renal function

          -  Acute or chronic acidosis or if there are plans to have a radiographic material
             containing iodine

          -  Have a clinically significant, active cardiovascular disease, or decompensated heart
             failure

          -  Treatment with systemic corticosteroids within the past two months prior to screening