Trial · NCT00819741
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin A1c (HbA1c) | week -2 (screening), week 16 | Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment. |
| Secondary | Change in Fasting Plasma Glucose | week 0, week 16 | Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment. |
| Secondary | Change in 2-hour Postprandial Plasma Glucose | 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 |
| Secondary | Change in 7-point Plasma Glucose Profile | 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. |
| Secondary | Change in Fasting Serum Insulin | Week 0, week 16 | Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment. |
| Secondary | Change in 2-hour Postprandial Serum Insulin | Week 0, week 16 | Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment. |
| Secondary | Change in Fasting Serum C-peptide | Week 0, week 16 | Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment |
| Secondary | Change in 2-hour Postprandial Serum C-peptide | Week 0, week 16 | Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment |
| Secondary | Hypoglycaemic Episodes | 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. |
| Secondary | Change in Blood Pressure | Week 0, week 16 | Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment |
| Secondary | Physical Examinations | 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. |
| Secondary | ECG (ElectroCardioGram) | 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. |
| Secondary | Biochemistry: Alanine Aminotransferase (ALAT) | 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. |
| Secondary | Biochemistry: Alanine Aminotransferase (ASAT) | 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. |
| Secondary | Haematology: Haemoglobin | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00819741/registered