Delving into the Latest Updates on Isophane Protamine Human Insulin(Novo Nordisk A/S) with Synapse

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Start Date01 Apr 2024

Sponsor / Collaborator

Loyola University Medical Center

NCT01970241 / CompletedPhase 4IIT

Inpatient Diabetes on Corticosteroids

Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Start Date01 Jul 2014

Sponsor / Collaborator

Hennepin Healthcare Research Institute

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NCT00821795 / CompletedPhase 4

Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy

Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions:
To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital.
To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

Start Date11 Mar 2009

Sponsor / Collaborator

Lexington Va Medical Center

[+1]

100 Clinical Results associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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100 Translational Medicine associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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100 Patents (Medical) associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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Literatures (Medical) associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

01 Dec 2017·Biomedicine & PharmacotherapyQ2 · MEDICINE

Aloe vera gel improves behavioral deficits and oxidative status in streptozotocin-induced diabetic rats

Q2 · MEDICINE

Article

Author: Farbood, Yaghoob ; Tabatabaei, Seyed Reza Fatemi ; Rashno, Masome ; Ghaderi, Shahab ; Bahrami-Tapehebur, Mohammad

Oxidative stress has a major role in progression of diabetes-related behavioral deficits. It has been suggested that Aloe vera has anti-diabetic, antioxidative, and neuroprotective effects. The present study was designed to determine the effects of Aloe vera gel on behavioral functions, oxidative status, and neuronal viability in the hippocampus of streptozotocin (STZ)-induced diabetic rats. Fifty five adult male Wistar rats were randomly divided into five groups, including: control (normal saline 8ml/kg/day; P.O.), diabetic (normal saline 8ml/kg/day; P.O.), Aloe vera gel (100mg/kg/day; P.O.), diabetic+Aloe vera gel (100mg/kg/day; P.O.) and diabetic+NPH insulin (10 IU/kg/day; S.C.). All treatments were started immediately following confirmation of diabetes in diabetic groups and were continued for eight weeks. Behavioral functions were evaluated by employing standard behavioral paradigms. Additionally, oxidative status and neuronal viability were assessed in the hippocampus. The results of behavioral tests showed that diabetes enhanced anxiety/depression-like behaviors, reduced exploratory and locomotor activities, decreased memory performance, and increased stress related behaviors. These changes in diabetic rats were accompanied by increasing oxidative stress and neuronal loss in the hippocampus. Interestingly, eight weeks of treatment with Aloe vera gel not only alleviated all the mentioned deficits related to diabetes, but in some aspects, it was even more effective than insulin. In conclusion, the results suggest that both interrelated hypoglycemic and antioxidative properties of Aloe vera gel are possible mechanisms that improve behavioral deficits and protect hippocampal neurons in diabetic animals.

01 Jun 2017·Diabetes Care

Insulin-Induced Distant Site Lipoatrophy

Letter

Author: Atsumi, Tatsuya ; Takeuchi, Jun ; Miyoshi, Hideaki ; Nakamura, Akinobu ; Kondo, Aki

A 46-year-old Japanese woman with type 2 diabetes noticed a depression in her right anterior abdomen where she had previously injected insulin for approximately 9 months (human neutral protamine Hagedorn insulin and insulin lispro), and this lesion expanded to her right groin. About 18 months after the insulin injections were stopped, a second depression lesion appeared on her left buttock where she had never injected insulin (Fig. 1 A–C ). Computed tomography showed lipoatrophy of the right submandibular region, right anterior abdomen, and left buttock sites (Fig. 1 D and E ). Laboratory data showed high values of HbA1c (8.9% [73 mmol/mol]) and fasting insulin levels (1,163 µU/mL). The insulin antibody titer was over 5,000 nU/mL, and the binding rate was 86.7%. Insulinoma was negative, with no increase in her fasting C-peptide level, …

01 Jun 2013·Diabetes Technology & TherapeuticsQ2 · MEDICINE

A Prospective, Randomized, Open-Label Study Comparing the Efficacy and Safety of Preprandial and Prandial Insulin in Combination with Acarbose in Elderly, Insulin-Requiring Patients with Type 2 Diabetes Mellitus

Q2 · MEDICINE

Article

Author: Gong, Yanping ; Li, Chunlin ; Tian, Hui ; Yang, Guang ; Cheng, Xiaoling ; Li, Jian

BACKGROUNDBy delaying absorption of carbohydrates, acarbose can reduce preprandial hyperglycemia and delay the emergence of postprandial hyperglycemia.PATIENTS AND METHODSTo evaluate whether acarbose can shorten the desirable time interval between insulin injection and meals, 60 elderly (≥60 years) patients with unsatisfactorily controlled type 2 diabetes mellitus despite insulin use were enrolled in a randomized, open-label study of 16 weeks' duration. Two groups (n=20 each) were randomized to receive isophane protamine biosynthetic human insulin 70/30 injections twice daily 30 min before meals plus acarbose 50 mg once daily (Group A) or three times daily (Group B) before meals, whereas the third group (n=20) received isophane protamine biosynthetic human insulin 70/30 injections twice daily immediately before meals plus acarbose 50 mg three times daily before meals (Group C).RESULTSThe required insulin dosage at study end was significantly less in Groups B and C than in Group A. Both continuous glucose monitoring data and the patients' self-monitoring data indicated that blood glucose variability parameters were significantly improved in Groups B and C in comparison with Group A, but there were no significant differences between Groups B and C. The incidence of hypoglycemia was low in all three groups.CONCLUSIONSThe absence of a significant difference in glucose variability between Groups B and C suggests that the addition of acarbose permitted adjustment of the insulin administration time from 30 min before meals to immediately before meals-which may be more convenient for patients-without affecting glycemic control.

100 Deals associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Novo Nordisk China Pharmaceuticals Co. Ltd.	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	NO	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	MK	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	HR	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	BE	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	DK	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	RU	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	PL	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	SE	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	FR	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 1	SK	Novo Nordisk A/S	01 Mar 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00821795 (VIISTA, CTgov)	Phase 4	Diabetes Mellitus, Type 2	120	NPH/Regular 70/30 mix (NPH/Regular 70/30 Mix)	qthoztjhzw(zbhqfooklw) = cshpfnoldp pcynutyqig (qhikweawts, touvxgivga - qubxhoyeks) View more	-	04 Mar 2020
				insulin aspart protamine/insulin aspart 70/30 mix (Aspart Insulin Analog Biphasic Mix)	qthoztjhzw(zbhqfooklw) = ufwtjuyiec pcynutyqig (qhikweawts, lzloxaxgxj - bdqkrowpfk) View more