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62 Diseases |  |
26 Trials |
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26 Trials |  |
826 News |  |
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- | Tresiba (insulin degludec) / Novo Nordisk, Lantus (insulin glargine) / Sanofi, NovoLog (insulin aspart) / Novo Nordisk
Journal: Expanded table: some available insulins for type 2 diabetes. (Pubmed Central) - Aug 6, 2019
No abstract available
- | NovoLog (insulin aspart) / Novo Nordisk
Clinical, Journal: Impact of a Basal-Bolus Insulin Regimen on Metabolic Control and Risk of Hypoglycemia in Patients With Diabetes Undergoing Peritoneal Dialysis. (Pubmed Central) - Jul 28, 2019
No abstract available An intervention consisting of an educational program and a basal-bolus insulin regimen in type 1 and type 2 diabetes mellitus patients undergoing PD caused a decrease in HbA1c levels, and mean blood glucose levels as measured from CGM with no significant increases in hypoglycemia episodes.
- | Trial completion, Enrollment change, Metastases: Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy? (clinicaltrials.gov) - Jul 22, 2019
P=N/A, N=20, Completed, Sponsor: University of California, San Francisco
An intervention consisting of an educational program and a basal-bolus insulin regimen in type 1 and type 2 diabetes mellitus patients undergoing PD caused a decrease in HbA1c levels, and mean blood glucose levels as measured from CGM with no significant increases in hypoglycemia episodes. Recruiting --> Completed | N=40 --> 20
- | Tresiba (insulin degludec) / Novo Nordisk
Journal: Solution structures of long-acting insulin analogues and their complexes with albumin. (Pubmed Central) - Jul 19, 2019
Measurements of size-exclusion chromatography coupled to SAXS revealed a complex between a degludec dihexamer and albumin. Based on the results, equilibria for the albumin-detemir and albumin-degludec mixtures are proposed.
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion: A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine (clinicaltrials.gov) - Jul 17, 2019
P=N/A, N=12847, Completed, Sponsor: Novo Nordisk A/S
Based on the results, equilibria for the albumin-detemir and albumin-degludec mixtures are proposed. Not yet recruiting --> Completed
- | Tresiba (insulin degludec) / Novo Nordisk
Journal: Risk stratification of persons on premixed insulin in Ramadan. (Pubmed Central) - Jul 11, 2019
In spite of evidence to the contrary, all persons using premixed insulin are categorized as having high risk. In this article, we present data from randomized controlled trials, and discuss the placement of premixed insulin in the risk stratification framework.
- | Lantus (insulin glargine) / Sanofi, Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim
Clinical, Journal: Severe atypical ketoacidosis due to SGLT2-inhibitor therapy : Two case reports (Pubmed Central) - Jun 28, 2019
Treatment with intravenous fluid replacement, insulin, glucose, potassium and buffer solution led to a normalisation of pH and serum glucose levels. Our report describes two cases of atypical ketoacidosis with moderately elevated serum glucose during sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy.
- | Lantus (insulin glargine) / Sanofi, NovoLog (insulin aspart) / Novo Nordisk
Journal: Identification of N-Terminally Truncated Derivatives of Insulin Analogs Formed in Pharmaceutical Formulations. (Pubmed Central) - Jun 24, 2019
Our report describes two cases of atypical ketoacidosis with moderately elevated serum glucose during sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy. The following derivatives formed by truncation of the B chain in insulin analogs were identified in pharmaceutical formulations: desPhe-N-formyl-Val derivative, desPhe derivative, pyroGlu derivative.
- | DegludecPlus (insulin degludec/insulin aspart) / Novo Nordisk
Clinical, Journal: Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: a randomized trial. (Pubmed Central) - May 31, 2019
The following derivatives formed by truncation of the B chain in insulin analogs were identified in pharmaceutical formulations: desPhe-N-formyl-Val derivative, desPhe derivative, pyroGlu derivative. IDegAsp+IAsp was non-inferior to IDet+IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.
- |||||| Levemir (insulin detemir rDNA origin) / Novo Nordisk
New trial: A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine (clinicaltrials.gov) - May 22, 2019
P, N=10000, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Also ich hab ausschließlich für Nachts Levemir (ebenfalls @novonordisk) und komme da recht schön morgens zwischen 100 und 120 raus... (Twitter) - May 17, 2019
- | Victoza (liraglutide) / Novo Nordisk
Journal: Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection Versus Insulin Alone in Type 2 Diabetes. (Pubmed Central) - May 15, 2019
Similarly there were no treatment group differences in measures of myocardial fatty acid uptake or handling, and no differences in total oxidation rate. These observations argue against large effects of GLP-1 agonists on myocardial fuel metabolism as mediators of beneficial treatment effects on myocardial function and ischemia protection.
- | Lantus (insulin glargine) / Sanofi, Levemir (insulin detemir rDNA origin) / Novo Nordisk
Clinical, Journal: Insulin Detemir Versus Insulin Glargine in the Hospital: Do Hypoglycemia Rates Differ? (Pubmed Central) - May 7, 2019
This retrospective cohort study compared hypoglycemia rates between the two basal insulin analogs in hospitalized patients with diabetes. No difference was found between the two insulin cohorts in the proportion of patients who experienced hypoglycemic events.
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion date, Trial primary completion date: CF-IDEA: Cystic Fibrosis - Insulin Deficiency, Early Action (clinicaltrials.gov) - Apr 20, 2019
P3, N=100, Recruiting, Sponsor: Sydney Children's Hospitals Network
No difference was found between the two insulin cohorts in the proportion of patients who experienced hypoglycemic events. Trial completion date: Jun 2019 --> Jun 2021 | Trial primary completion date: Dec 2018 --> Dec 2020
- || Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion date, Trial primary completion date: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry (clinicaltrials.gov) - Apr 20, 2019
P=N/A, N=2446, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Jun 2019 --> Jun 2021 | Trial primary completion date: Dec 2018 --> Dec 2020 Trial completion date: Dec 2019 --> Sep 2019 | Trial primary completion date: Dec 2019 --> Sep 2019
- |||| Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion date, Trial primary completion date, Combination therapy: EXPECT: Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes (clinicaltrials.gov) - Mar 11, 2019
P3, N=300, Recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Dec 2019 --> Sep 2019 | Trial primary completion date: Dec 2019 --> Sep 2019 Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2021 --> Oct 2021
- | Byetta (exenatide) / AstraZeneca
Trial completion date, Trial primary completion date: New Onset Type 1 Diabetes: Role of Exenatide (clinicaltrials.gov) - Jan 29, 2019
P4, N=20, Recruiting, Sponsor: Albert Einstein College of Medicine
Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2021 --> Oct 2021 Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Dec 2019
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment change, Trial withdrawal: RASCIN: Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin (clinicaltrials.gov) - Jan 16, 2019
P4, N=0, Withdrawn, Sponsor: University of Texas Southwestern Medical Center
Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Dec 2019 N=600 --> 0 | Recruiting --> Withdrawn
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment open, HEOR: Determin: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy (clinicaltrials.gov) - Oct 11, 2018
P4, N=216, Recruiting, Sponsor: The University of Texas Health Science Center, Houston
N=600 --> 0 | Recruiting --> Withdrawn Not yet recruiting --> Recruiting
- |||| Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi
Trial completion, HEOR, Real-world evidence, Real-world: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM) (clinicaltrials.gov) - Aug 24, 2018
P4, N=3311, Completed, Sponsor: Sanofi
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Enrollment open, Trial completion date, Trial primary completion date, Metastases: Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy? (clinicaltrials.gov) - Aug 21, 2018
P=N/A, N=40, Recruiting, Sponsor: University of California, San Francisco
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Aug 2018 --> Dec 2018 | Trial primary completion date: Feb 2018 --> Dec 2018
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion, Phase classification: Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes (clinicaltrials.gov) - Aug 20, 2018
P=N/A, N=181, Completed, Sponsor: Mackay Memorial Hospital
Not yet recruiting --> Recruiting | Trial completion date: Aug 2018 --> Dec 2018 | Trial primary completion date: Feb 2018 --> Dec 2018 Recruiting --> Completed | Phase classification: P4 --> PN/A
- | Trial completion, Trial completion date: Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients (clinicaltrials.gov) - Aug 17, 2018
P4, N=181, Completed, Sponsor: Mackay Memorial Hospital
Recruiting --> Completed | Phase classification: P4 --> PN/A Recruiting --> Completed | Trial completion date: May 2016 --> Aug 2016
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
New P4 trial, HEOR: Determin: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy (clinicaltrials.gov) - Aug 8, 2018
P4, N=216, Not yet recruiting, Sponsor: The University of Texas Health Science Center, Houston
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment change: Detemir: Role in Type 1 Diabetes (clinicaltrials.gov) - Jul 17, 2018
P4, N=18, Completed, Sponsor: Montefiore Medical Center
Recruiting --> Completed | Trial completion date: May 2016 --> Aug 2016 N=13 --> 18
- || Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion date, Trial primary completion date: IDIOM: Insulin Detemir in Obesity Management (clinicaltrials.gov) - Apr 25, 2018
P=N/A, N=240, Active, not recruiting, Sponsor: Vanderbilt University
N=13 --> 18 Trial completion date: Dec 2017 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2019
- | Victoza (liraglutide) / Novo Nordisk, Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion, Enrollment change: The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study (clinicaltrials.gov) - Apr 12, 2018
P4, N=157, Completed, Sponsor: University of Texas Southwestern Medical Center
Trial completion date: Dec 2017 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2019 Recruiting --> Completed | N=100 --> 157
- || Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment closed: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry (clinicaltrials.gov) - Mar 14, 2018
P=N/A, N=2446, Active, not recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Completed | N=100 --> 157 Enrolling by invitation --> Active, not recruiting
- | Byetta (exenatide) / AstraZeneca
Trial completion date, Trial primary completion date: New Onset Type 1 Diabetes: Role of Exenatide (clinicaltrials.gov) - Feb 7, 2018
P4, N=20, Recruiting, Sponsor: Albert Einstein College of Medicine, Inc.
Enrolling by invitation --> Active, not recruiting Trial primary completion date: Dec 2017 --> Dec 2018 | Trial completion date: Dec 2017 --> Jun 2019
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion: Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy (clinicaltrials.gov) - Feb 6, 2018
P=N/A, N=33, Completed, Sponsor: University of Colorado, Denver
Trial primary completion date: Dec 2017 --> Dec 2018 | Trial completion date: Dec 2017 --> Jun 2019 Active, not recruiting --> Completed
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion, Enrollment change, Trial primary completion date: Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) (clinicaltrials.gov) - Feb 1, 2018
P2, N=8, Completed, Sponsor: Wake Forest University Health Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed | N=36 --> 8 | Trial primary completion date: Mar 2017 --> Mar 2015
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk, Novolin R (recombinant human insulin) / Novo Nordisk, NovoLog (insulin aspart) / Novo Nordisk
Trial completion: NASO-PET: Effects of Intranasal Insulin Administration on Tissue Specific Insulin Sensitivity (clinicaltrials.gov) - Jan 26, 2018
P=N/A, N=10, Completed, Sponsor: Turku University Hospital
Active, not recruiting --> Completed | N=36 --> 8 | Trial primary completion date: Mar 2017 --> Mar 2015 Recruiting --> Completed
- || Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment change, Trial primary completion date: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry (clinicaltrials.gov) - Jan 25, 2018
P=N/A, N=2037, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Recruiting --> Completed N=3055 --> 2037 | Trial primary completion date: Jul 2020 --> Dec 2019
- | Januvia (sitagliptin) / Merck (MSD)
Trial completion, Trial primary completion date, Surgery: Sitagliptin in Non-Diabetic Patients Undergoing General Surgery (clinicaltrials.gov) - Jan 16, 2018
P4, N=80, Completed, Sponsor: Emory University
N=3055 --> 2037 | Trial primary completion date: Jul 2020 --> Dec 2019 Recruiting --> Completed | Trial primary completion date: Feb 2018 --> Apr 2017
- |||||||||| Levemir (insulin detemir rDNA origin) / Novo Nordisk
New P3 trial, Combination therapy: EXPECT: Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes (clinicaltrials.gov) - Dec 19, 2017
P3, N=300, Recruiting, Sponsor: Novo Nordisk A/S
- |||| Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi
Trial completion, HEOR, Real-world evidence, Real-world: REGAIN CONTROLt: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin (clinicaltrials.gov) - Nov 1, 2017
P4, N=609, Completed, Sponsor: Sanofi
Recruiting --> Completed | Trial primary completion date: Feb 2018 --> Apr 2017 Active, not recruiting --> Completed
- |||| Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi
Trial completion, HEOR, Real-world evidence, Real-world: Reach-Controlt: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Na (clinicaltrials.gov) - Oct 30, 2017
P4, N=705, Completed, Sponsor: Sanofi
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Victoza (liraglutide) / Novo Nordisk, Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion, Trial primary completion date: Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake (clinicaltrials.gov) - Oct 25, 2017
P=N/A, N=26, Completed, Sponsor: Indiana University
Active, not recruiting --> Completed Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Sep 2017
- ||| Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi
Enrollment closed, HEOR, Real-world evidence, Real-world: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM) (clinicaltrials.gov) - Oct 17, 2017
P4, N=3324, Active, not recruiting, Sponsor: Sanofi
Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Sep 2017 Recruiting --> Active, not recruiting
- | Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial primary completion date: CF-IDEA: Cystic Fibrosis - Insulin Deficiency, Early Action (clinicaltrials.gov) - Oct 4, 2017
P3, N=100, Recruiting, Sponsor: Sydney Children's Hospital Network
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Dec 2018
- Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial termination, Combination therapy: A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin (clinicaltrials.gov) - Sep 1, 2017
P3, N=42, Terminated, Sponsor: Novo Nordisk A/S
Trial primary completion date: Dec 2016 --> Dec 2018 Completed --> Terminated
- ||||||| Steglatro (ertugliflozin) / Pfizer, Merck (MSD)
Monotherapy: A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007). (clinicaltrials.gov) - Aug 29, 2017
P3, N=621, Completed, Sponsor: Merck Sharp & Dohme Corp.
Completed --> Terminated Active, not recruiting --> Completed
- Levemir (insulin detemir rDNA origin) / Novo Nordisk
Enrollment closed, Enrollment change: Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy (clinicaltrials.gov) - Jul 19, 2017
P=N/A, N=33, Active, not recruiting, Sponsor: University of Colorado, Denver
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting | N=60 --> 33
- |||||||||| Levemir (insulin detemir rDNA origin) / Novo Nordisk
New P3 trial: Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes. (clinicaltrials.gov) - Jul 18, 2017
P3, N=752, Completed, Sponsor: Novo Nordisk A/S
- |||| Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial completion: ADAPT: Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes (clinicaltrials.gov) - Jun 1, 2017
P4, N=520, Completed, Sponsor: Novo Nordisk A/S
Enrolling by invitation --> Active, not recruiting | N=60 --> 33 No longer recruiting --> Completed
- | Victoza (liraglutide) / Novo Nordisk, Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial primary completion date: The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study (clinicaltrials.gov) - May 3, 2017
P4, N=100, Recruiting, Sponsor: University of Texas Southwestern Medical Center
No longer recruiting --> Completed Trial primary completion date: Dec 2016 --> Dec 2017
- || Levemir (insulin detemir rDNA origin) / Novo Nordisk
Trial primary completion date: IDIOM: Insulin Detemir in Obesity Management (clinicaltrials.gov) - Apr 18, 2017
P=N/A, N=240, Active, not recruiting, Sponsor: Vanderbilt University
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Dec 2015 --> Dec 2017
- | Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Enrollment change, Trial termination, Trial primary completion date: Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog (clinicaltrials.gov) - Apr 7, 2017
P4, N=2, Terminated, Sponsor: Laniado Hospital
Trial primary completion date: Dec 2015 --> Dec 2017 N=20 --> 2 | Not yet recruiting --> Terminated | Trial primary completion date: Jun 2017 --> Feb 2017; Insufficient recruitment rate
- || Toujeo (Long-acting Recombinant Human Insulin Analogue) / Sanofi
Trial primary completion date, HEOR, Real-world evidence, Real-world: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM) (clinicaltrials.gov) - Mar 23, 2017
P4, N=3270, Recruiting, Sponsor: Sanofi
N=20 --> 2 | Not yet recruiting --> Terminated | Trial primary completion date: Jun 2017 --> Feb 2017; Insufficient recruitment rate Trial primary completion date: May 2018 --> Nov 2017
- | Bydureon (exenatide XR once-weekly) / AstraZeneca, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
Enrollment change, Trial withdrawal, Trial primary completion date, Combination therapy: Dexlar: Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes (clinicaltrials.gov) - Mar 3, 2017
P4, N=0, Withdrawn, Sponsor: Weill Medical College of Cornell University
Trial primary completion date: May 2018 --> Nov 2017 N=75 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2017 --> Jun 2018