| Trial ID: | L4368 |
| Source ID: | NCT00819741
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| Associated Drug: |
Repaglinide
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| Title: |
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
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00819741/results
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| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: repaglinide|DRUG: metformin|DRUG: repaglinide
|
| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin A1c (HbA1c), Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment., week -2 (screening), week 16 | Secondary: Change in Fasting Plasma Glucose, Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment., 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, 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., 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., 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., 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, 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, 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., Weeks 0-16|Change in Blood Pressure, Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment, 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., 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., 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., 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., 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., Week -2, week 16
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| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
433
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2009-02
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| Completion Date: |
2009-11
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| Results First Posted: |
2010-12-08
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| Last Update Posted: |
2017-02-10
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| Locations: |
Novo Nordisk Investigational Site, Fuzhou, Fujian, 350001, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210009, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210012, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210029, China|Novo Nordisk Investigational Site, Suzhou, Jiangsu, 215004, China|Novo Nordisk Investigational Site, Wuxi, Jiangsu, 214023, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200001, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200025, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200072, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200092, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200120, China|Novo Nordisk Investigational Site, Hangzhou, Zhejiang, 310003, China|Novo Nordisk Investigational Site, Wenzhou, Zhejiang, 325000, China|Novo Nordisk Investigational Site, Hangzhou, 310016, China|Novo Nordisk Investigational Site, Nantong, 226001, China|Novo Nordisk Investigational Site, Shanghai, 200040, China
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| URL: |
https://clinicaltrials.gov/show/NCT00819741
|
