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

Change in Fasting Plasma Glucose

Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.

Time frame: week 0, week 16

Change in 2-hour Postprandial Plasma Glucose

Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment

Time frame: Week 0, week 16

Change in 7-point Plasma Glucose Profile

Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.

Time frame: Week 0, week 16

Change in Fasting Serum Insulin

Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.

Time frame: Week 0, week 16

Change in 2-hour Postprandial Serum Insulin

Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.

Time frame: Week 0, week 16

Change in Fasting Serum C-peptide

Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment

Time frame: Week 0, week 16

Change in 2-hour Postprandial Serum C-peptide

Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment

Time frame: Week 0, week 16

Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Time frame: Weeks 0-16

Change in Blood Pressure

Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment

Time frame: Week 0, week 16

Physical Examinations

The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.

Time frame: Week -2, week 16

ECG (ElectroCardioGram)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Time frame: Week -2, week 16

Biochemistry: Alanine Aminotransferase (ALAT)

The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Time frame: Week -2, week 16

Biochemistry: Alanine Aminotransferase (ASAT)

The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Time frame: Week -2, week 16

Haematology: Haemoglobin

Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Time frame: Week -2, week 16