Trial · NCT01453049
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline (Week 0) and Week 24 | Full Analysis Set (FAS): all randomized participants who received \>=1 dose of study medication and had \>=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed. | Percent of total hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline (Week 0) and Week 24 | FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Number of HbA1c Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of FPG Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Picomoles per liter (pmol/L) | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Ratio: FI*FG (num.); 22.5 (denom.) | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Ratio: 20*FI (num.); FG-3.5 (denom.) | MEAN |
| SECONDARY | Number of Participants at Various Dose Levels at Week 24/EW | Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm. | participants | NUMBER |
| SECONDARY | Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW | Baseline (Week 0) and Week 24/EW | Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | ratio | MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | mmol/L | MEAN |
| SECONDARY | Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Hypoglycemic Events | Week 24/EW | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Hypoglycemic Events | Week 24/EW | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Hypoglycemic events | NUMBER |
| SECONDARY | Number of Participants With a Bone Fracture | Week 24/EW | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW | Baseline (Week 0) and Week 24/EW | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Giga per liter (10^9/L) cells | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01453049/outcomes