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Protaphane Medical Research Studies

Up-to-date List of Protaphane Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Protaphane Medical Research Studies

Rank Status Study
1 Recruiting Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Condition: Diabetes During Pregnancy
Interventions: Drug: NPH;   Drug: Insulin LISPRO;   Drug: Insulin glulisine
Outcome Measures: show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus;   Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge;   Compare A1C at enrollment and weekly until delivery;   Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
2 Not yet recruiting A Study to Compare and Measure the Effects of Insulin Peglispro and Glargine on Meal Time Insulin Requirements
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Insulin Peglispro;   Drug: Insulin Lispro;   Drug: Insulin Glargine
Outcome Measures: Pharmacodynamics: Plasma Glucose Area Under the Concentration Curve (AUC), Above Pre Meal Baseline for Insulin Lispro;   Pharmacokinetics: Area Under the Concentration Curve (AUC) for Prandial Insulin Lispro;   Pharmacodynamics: Average Glucose Infusion Rate from Euglycemic 2-step Hyperinsulinemic Clamp (M-value);   Pharmacokinetics: Area Under the Concentration Curve (AUC) for Paracetamol;   Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS);   Pharmacodynamics: Area Under the Concentration Curve for Triglyceride;   Pharmacokinetics: Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp
3 Unknown  The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism
Condition: Diabetes
Interventions: Drug: central insulin;   Drug: Placebo
Outcome Measures: Insulin sensitivity;   Energy metabolism
4 Not yet recruiting The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Conditions: Diabetes Mellitus, Type 2;   Diabetes
Interventions: Drug: Metformin;   Drug: Detemir;   Drug: Liraglutide;   Drug: Insulin Aspart
Outcome Measures: Composite end-point;   Mean change from randomization in A1c at week 26;   Percentage of patients reaching target A1c of <7% at week 26;   Percentage of patients reaching pre-specified "treatment failure" outcome;   Mean change from randomization in body weight;   Percentage of patients who lost 5% or more of body weight from randomization;   Hypoglycemic episodes;   Percentage of patients experiencing any hypoglycemic episode;   Diabetes Quality of Life (DQOL)questionnaire score;   Short Form-36 (SF-36) questionnaire score;   Number of daily injections;   Health care cost, total;   Health care cost, diabetes-related;   Number of titration events by healthcare professional;   Number of titration events by patient;   Healthcare provider time during scheduled office (minutes/visit);   Healthcare provider time, unscheduled (total minutes);   Compliance with pharmacologic therapy;   Change in LDL cholesterol from baseline to week 26;   Change in triglycerides from baseline;   7-point glucose profiles over 2 consecutive days
5 Not yet recruiting PK/PD STUDY OF U-500 REGULAR INSULIN
Conditions: Type 2 Diabetes;   Insulin Resistance;   High Insulin Requirements
Intervention: Drug: U-500 insulin
Outcome Measures: Duration (in hours) of 20 % dextrose infusion requirement;   Peak 20 % dextrose requirement.;   Area under the curve (AUC) of 20 % dextrose
6 Unknown  Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes
Condition: Type 2 Diabetes
Interventions: Drug: Gliclazide MR and Insulin Glargine Injection;   Drug: Biosynthetic Human Insulin Injection
Outcome Measures: Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG;   MBG, SDBG, MAGE and MODD in the 48th CGMS;   Incidence of hypoglycemia and severe hypoglycemia;   Weight change
7 Recruiting Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Condition: Post-Transplant Glucocorticoid Induced Diabetes
Interventions: Drug: Neutral protamine hagedorn (NPH) insulin;   Drug: Regular human insulin or Insulin Aspart;   Drug: Insulin glargine
Outcome Measures: Blood glucose - inpatient;   Post prandial blood glucose - inpatient;   Length of inpatient hospital stay;   Blood glucose;   Hemoglobin A1C;   Post prandial blood glucose;   Hypoglycemic episodes;   Glycemic treatment failure;   Cardiovascular events;   Post-transplant infections or new antibiotic use;   Transplant graft failure;   New acute renal failure;   Mortality
8 Recruiting A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Conditions: Diabetes;   Diabetes Mellitus, Type 1
Interventions: Drug: insulin degludec/insulin aspart;   Drug: insulin aspart;   Drug: insulin detemir
Outcome Measures: Change from baseline in HbA1c (glycosylated haemoglobin) (%);   Change from baseline in fasting plasma glucose;   Incidence of treatment emergent adverse events (TEAEs);   Number of treatment emergent confirmed hypoglycaemic episodes (plasma glucose (PG) below 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia);   Number of treatment emergent nocturnal confirmed hypoglycaemic episodes;   Number of hyperglycaemic episodes (PG above 14.0 mmol/L (250 mg/dL) where subject looks/feels ill;   Number of hyperglycaemic episodes (PG above 14.0 mmol/L (250 mg/dL) where subject looks/feels ill with ketosis (blood ketones above 1.5 mmol/L)
9 Recruiting Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Saxagliptin 5mg;   Drug: Placebo for Saxagliptin
Outcome Measures: The change in glycosylated hemoglobin A1c (HbA1c) from baseline to Week 24 (prior to rescue/censoring);   The change from baseline to Week 24 (prior to rescue/censoring) in the postprandial plasma glucose (PPG) area under the curve (AUC) from 0 to 180 minutes in response to a meal tolerance test;   The change from baseline to Week 24 (prior to rescue/censoring) in 120-minute postprandial plasma glucose (PPG) in response to a meal tolerance test;   The proportion of subjects achieving a therapeutic glycaemic response at Week 24 (prior to rescue/censoring) defined as HbA1C <7%;   The change from baseline to the mean of Weeks 20 and 24 (prior to rescue/censoring) in fasting plasma glucose (FPG);   The change in mean total daily dose of insulin (MTDDI) from baseline to Week 24 (regardless of rescue/censoring)
10 Recruiting Regulation of Endogenous Glucose Production by Brain Insulin Action
Condition: Insulin Resistance, Diabetes
Intervention: Drug: Intranasal insulin
Outcome Measure: Endogenous glucose production
11 Unknown  PK/PD Study of Intranasal Insulin in Type I Diabetes
Condition: Type 1 Diabetes
Interventions: Drug: Insulin;   Drug: Insulin LISPRO
Outcome Measure: Insulin tolerability, PK, and PD
12 Recruiting A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification
Conditions: Diabetes;   Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec/liraglutide;   Drug: insulin aspart
Outcome Measures: Change from baseline in HbA1c (glycosylated haemoglobin);   Change from baseline in body weight;   Number of treatment-emergent confirmed hypoglycaemic episodes
13 Recruiting Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation
Condition: Hyperglycemia
Interventions: Drug: Insulin lispro, Humalog (Eli Lilly) in insulin pump;   Drug: Human insulin isophane, Humulin N (Eli Lilly);   Other: Standard of care
Outcome Measures: Glycosylated hemoglobin (HbA1c);   Oral glucose tolerance test (OGTT)-derived 2 hour-glucose;   Fasting glucose;   Beta cell function;   Insulin sensitivity;   Daily glucose measurements;   Serum creatinine
14 Unknown  Comparing Long-acting Insulins During Exercise in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Insulin glargine;   Drug: Insulin detemir
Outcome Measures: Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise);   Lactate;   NEFA (Non-esterified fatty acids);   B-OHB (beta-hydroxybutyrate);   Catecholamines;   Glucagon;   Human growth hormone (hGH);   Cortisol;   IL-6 (interleukin 6);   High sensitivity CRP (Hs-CRP);   RQ (Respiratory Quotient);   Frequency of hypoglycaemic events;   Time spent in hypoglycaemia;   Blood glucose
15 Recruiting Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
Interventions: Drug: lixisenatide (AVE0010);   Drug: insulin glulisine (HMR1964)
Outcome Measures: Change from baseline in HbA1c;   Change from baseline in body weight;   Percentage of patients reaching HbA1c <7%;   Percentage of patients reaching HbA1c ≤6.5%;   Change in body weight from baseline;   Percentage of patients with no weight gain;   Change in 7-point SMPG profiles from baseline;   Change from baseline in FPG;   Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients);   Change from baseline in insulin glargine dose;   Daily dose of insulin glulisine;   Total daily dose of insulin;   Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year);   Severe hypoglycemia
16 Unknown  Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice
Condition: Type 1 Diabetes
Intervention: Device: Diabetes Interactive Diary (DID)
Outcome Measures: Blood levels of glycosylated hemoglobin;   blood glucose (BG) levels;   Glucose variability;   Change in body weight and BMI;   Total daily insulin dose, total basal insulin dose, total prandial insulin dose;   Quality of life;   Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall;   Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall;   Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)
17 Unknown  Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
Condition: Insulin-requiring Type 2 Diabetes Mellitus
Interventions: Drug: nph insulin;   Drug: human insulin;   Drug: Insulin Glargine;   Drug: Insulin glulisine
Outcome Measures: Fasting Intact Proinsulin;   Weight;   hsCRP;   Adiponectin;   MMP-9;   OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks;   HOMA-IR score;   HbA1c;   Fasting intact Proinsulin;   Glucose;   Responder rate;   Hypoglycemic events.
18 Recruiting Metabolic Signalling in Muscle- and Adipose-tissue Following Insulin Withdrawal and Growth Hormone Injection.
Conditions: Diabetes Mellitus Type I;   Ketoacidosis
Interventions: Drug: Insulin withdrawal;   Drug: Norditropin
Outcome Measures: Insulin and growth hormone signalling, expressed as CHANGE in phosphorylation of intracellular target proteins and CHANGE in mRNA expression of target genes in muscle- and fat-tissue.;   Change in Intracellular markers of lipid metabolism in muscle- and fat tissue biopsies.;   Metabolism
19 Recruiting A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
Conditions: Diabetes;   Diabetes Mellitus, Type 1
Interventions: Drug: insulin degludec;   Drug: insulin glargine;   Drug: insulin aspart
Outcome Measures: Number of treatment emergent severe or BG (blood glucose) confirmed symptomatic hypoglycaemic episodes during the maintenance period;   Number of treatment emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period;   Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period;   Incidence of treatment emergent adverse events;   Change from baseline in HbA1c (glycosylated haemoglobin);   FPG (Fasting plasma glucose)
20 Unknown  Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone
Condition: Acute Coronary Syndrome
Interventions: Drug: glucose insulin potassium;   Drug: GIK and intensive insulin therapy
Outcome Measures: 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke.;   Severe dysrhythmias, acute left ventricular failure with ejection fraction<45%, change of serum B-type natriuretic peptide (BNP), serum troponin, and platelet factor activator (PFA-100) within 24 hours after the start of protocol treatment.

These studies may lead to new treatments and are adding insight into Protaphane etiology and treatment.

A major focus of Protaphane research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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