Trial · NCT03100058
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Body Weight at 24 Weeks | Baseline, Week 24 (Epoch 3) | Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment |
| Secondary | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study | Baseline, Week 24 | Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline |
| Secondary | Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups | Baseline, Week 24 | Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM) |
| Secondary | Percentage Change From Baseline on Waist Circumference | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake). |
| Secondary | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM) | Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4) | HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4) | At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured |
| Secondary | Change From Baseline in 24-hour Urinary Glucose Excretion | Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4) | Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory. |
| Secondary | Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4) | Between Week 24 and Week 48 (Epoch 4) | Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4) |
| Secondary | Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion | Baseline, Week 24 | Evaluation of 24-hour urinary calcium excretion after 24 week of treatment. |
| Secondary | Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion | Baseline, Week 24, Week 48 | Evaluation of 24-hour urinary calcium after 48 weeks of treatment |
| Secondary | Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion | Week 24, Week 48 | Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment |
| Secondary | Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion | Week 24, Week 48 | Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment |
| Secondary | Change From Baseline in Fasting Lipid Profile (Lipoproteins) | Baseline, Week 24, Week 24 to Week 48 (Epoch 4) | Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48 |
| Secondary | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) | Baseline to Week 24, Week 24 to Week 48 (Epoch 4) | Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48 |
| Secondary | Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol) | Baseline to Week 24, Week 24 to Week 48 (Epoch 4) | Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48 |
| Secondary | Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax) | Summary at Week 24 from qd or bid regimens | Observe maximum plasma concentration following administration of LIK066 (Cmax) |
| Secondary | Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax) | Summary at Week 24 for qd or bid regimens | Time to reach the maximum concentration after administration of LIK066 (Tmax) |
| Secondary | Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t) | Summary at Week 24 from qd or bid regimens (0-6h) | Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t) |
| Secondary | Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast) | Summary at Week 24 from qd or bid regimens | Last non-zero concentration area under the curve (AUClast) |
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.
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GET https://conductscience.org/api/trials/v1/NCT03100058/registered