CLINICAL TRIALS PROFILE FOR INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

All Clinical Trials for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00658099 ↗	Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®	Completed	Novo Nordisk A/S		2007-11-01	This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
NCT00665808 ↗	Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany	Completed	Novo Nordisk A/S		2007-10-01	This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
NCT01122979 ↗	Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.	Completed	Sanofi	Phase 4	2010-07-01	Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: - Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. - Incidence of confirmed symptomatic and nocturnal hypoglycemia. - Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. - Creatinine clearance at baseline and after each period of treatment. - Overall safety: Incidence of adverse events.
NCT01680185 ↗	Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation	Completed	Medical University of Vienna	Phase 3	2012-08-01	The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.
NCT01790438 ↗	A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 3	2013-03-01	The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: - Change in participants' overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low night time blood sugar episodes - The total number of low blood sugar episodes reported
NCT01963728 ↗	Comparison of Insulin Therapy in Treating Post-Transplant Diabetes	Terminated	Inova Health Care Services	Phase 4	2014-05-01	To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

Clinical Trial Conditions for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human

Condition Name

Condition Name for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	3
Diabetes	2
Hyperglycemia	2

Condition MeSH

Condition MeSH for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Intervention	Trials
Diabetes Mellitus	7
Diabetes Mellitus, Type 2	4
Hyperglycemia	2
Diabetes Mellitus, Type 1	1

Clinical Trial Locations for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human

Trials by Country

Trials by Country for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Location	Trials
United States	16
Germany	4
Canada	4
Burkina Faso	2
Spain	1

Trials by US State

Trials by US State for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Location	Trials
Virginia	1
Washington	1
Tennessee	1
South Carolina	1
Pennsylvania	1

Clinical Trial Progress for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human

Sponsor Name

Sponsor Name for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Sponsor	Trials
Novo Nordisk A/S	2
Medical University of Vienna	2
Profil Institut für Stoffwechselforschung GmbH	2

Sponsor Type

Sponsor Type for Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human
Sponsor	Trials
Other	11
Industry	8