NCT Number: NCT00819741
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Novo Nordisk Investigational Site, Fuzhou, Fujian, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: week -2 (screening), week 16
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
Time frame: week 0, week 16
Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.
Time frame: Week 0, week 16
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
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
Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.
Time frame: Week 0, week 16
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
Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment
Time frame: Week 0, week 16
Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment
Time frame: Weeks 0-16
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: Week 0, week 16
Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment
Time frame: Week -2, week 16
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
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
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
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
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.
Novo Nordisk A/S
Industry
A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsNCT04286555
Cardiovascular Diseases, Diabetes
Baltimore, Maryland, United States
View Trial DetailsNCT07524166
Diabete Mellitus, Diabetes
Jiaxing, Zhejiang, China
View Trial DetailsNCT06094920
Albuminuria, CKD
Almelo, Overijssel, Netherlands
View Trial Details