Clinical trials: Variability
Clexane is Administered to Healthy Volunteers
A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions
Primary: To examine the within subject variability of Clexane (80 mg) in healthy male and female volunteers administered subcutaneously (s.c.) as a single dose, in two periods, under fasting conditions.
- Trial name
- NCT02081950
- Testing
- Enoxaparin sodium
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Chemi S.p.A.
Diabetes Mellitus, Type 2
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes…
- Trial name
- NCT01947855
- Testing
- Empagliflozin
- Where
- 2 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 1
A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes
The purpose of this study is to measure how much of the study drug or insulin glargine gets into the blood stream and how long it takes the body to get rid of it. The effect of exercise will also be evaluated.
- Trial name
- NCT01784211
- Testing
- LY2605541, Insulin Glargine
- Where
- Germany
- Volunteers
- 76 people
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus, Type 2
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient…
- Trial name
- COMETA (NCT03267576)
- Testing
- Canagliflozin 300 mg, Sitagliptin 100 mg, Metformin
- Where
- 5 sites in Mexico
- Volunteers
- 64 people
- Sponsor
- Janssen Research & Development, LLC
Type 2 Diabetes, Hypoglycemia
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who…
- Trial name
- GLOBE (NCT02007278)
- Testing
- vildagliptin and metformin (combination), glimepiride, Metformin
- Where
- 8 sites in Colombia
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Hepatocellular Carcinoma
Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
The purpose of this study is to characterize the baseline variability of a panel of tissue (tumor and adjacent) and blood-based biomarkers obtained from participants with hepatocellular carcinoma (HCC).
- Trial name
- NCT01521780
- Testing
- MRI, Pathology, Blood Samples
- Volunteers
- 12 people
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus
Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.
- Trial name
- VARIABLE (NCT01910441)
- Testing
- Vildagliptin, Glimepiride, Metformin
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Anemia
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta).
- Trial name
- NCT01356589
- Where
- 33 sites in Greece
- Volunteers
- 1,288 people
- Sponsor
- Hoffmann-La Roche
Heart Failure
Pressure Variability Study
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.
- Trial name
- APVS (NCT02943941)
- Testing
- Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
Type 2 Diabetes Mellitus
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once…
- Trial name
- TRACK (NCT02771093)
- Testing
- Trelagliptin, Alogliptin
- Where
- Japan
- Volunteers
- 27 people
- Sponsor
- Takeda
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Type 2 Diabetes Mellitus
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02318693
- Testing
- Sitagliptin, Glibenclamide
- Volunteers
- 53 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, Neuromuscular Blockade
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness.
- Trial name
- NCT01450813
- Testing
- Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg, Rocuronium 0.4 mg/kg
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medtronic - MITG
Type 1 Diabetes Mellitus
Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus.
- Trial name
- inRange (NCT04075513)
- Testing
- Insulin glargine, 300 U/ml, Insulin degludec, 100U/ml, Background therapy: Rapid acting insulin analogs
- Where
- 7 sites in United States, Brazil and 5 more
- Volunteers
- 343 people
- Sponsor
- Sanofi
Intra-subject Variability of Pharmacokinetics
Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
Objectives: To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule doses of 20 mg lomitapide.
- Trial name
- NCT01915771
- Testing
- lomitapide
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Diabetes, Diabetes Mellitus, Type 1
Observational Study to Evaluate the Safety of Levemir® in Diabetes
This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- PREDICTIVE™ (NCT00659295)
- Testing
- insulin detemir
- Where
- 13 sites in Belgium, Czechia and 11 more
- Volunteers
- 51,170 people
- Sponsor
- Novo Nordisk A/S