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Insulin Glargine

Lantus · Toujeo · Basaglar · Long-acting insulin

Insulin & Glucose RegulationApproved
MW
6063g/mol
Formula
C267H404N72O78S6

Insulin glargine is a long-acting human insulin analogue produced in recombinant form, primarily synthesized in laboratories for therapeutic use in managing diabetes mellitus. Researchers primarily study insulin glargine for its effectiveness in providing stable basal insulin levels with minimal risk of hypoglycemia compared to traditional insulins. Key findings indicate that insulin glargine achieves equivalent glycemic control to other insulins while significantly reducing nocturnal hypoglycemia incidents, particularly in patients transitioning from twice-daily regimens. Additionally, clinical evidence suggests that newer formulations, such as concentrated insulin glargine, may further enhance glycemic control with a lower incidence of adverse effects. Current research continues to explore its immunogenicity and long-term efficacy, underscoring its clinical relevance in diabetes management.

Overview

Übersicht

Insulin glargine is a synthetic, long-acting insulin analogue designed to mimic the basal insulin secretion of the pancreas. It is produced through recombinant DNA technology using Escherichia coli bacteria. As a member of the insulin class of hormones, it is primarily used in the management of diabetes mellitus. Researchers have focused on its ability to provide a steady insulin level, which is beneficial for maintaining baseline glucose control without the pronounced peaks associated with other insulin types. Insulin glargine plays a crucial role in glucose regulation by facilitating cellular glucose uptake, thus lowering blood glucose levels. It is primarily used in research concerning diabetes management and insulin therapy optimization. The mechanism of action involves binding to insulin receptors on cell surfaces, initiating a cascade that promotes glucose uptake and utilization. This action is crucial for maintaining normal blood glucose levels and preventing hyperglycemia. Insulin glargine is characterized by its prolonged duration of action, typically administered once daily. It does not have a defined peak effect, which reduces the risk of hypoglycemia, particularly nocturnal episodes. Its pharmacokinetic properties include a slow, steady release into the bloodstream, offering consistent glycemic control. Clinically, insulin glargine is used in both type 1 and type 2 diabetes management. It is approved by regulatory authorities such as the FDA and is available under various brand names, including Lantus, Toujeo, and Basaglar. Researchers have found it to be effective in achieving target blood glucose levels with a lower incidence of hypoglycemia compared to other basal insulins. Its use requires careful dose titration and monitoring to ensure optimal therapeutic outcomes.

Chemical profile

Chemische Struktur

Chemical structure of Insulin Glargine
FormelC267H404N72O78S6
Molekulargewicht6063g/mol
CAS-Nummer160337-95-1
PubChem CID118984454
Mechanism

Wirkmechanismus

Insulin glargine acts on insulin receptors, activating the insulin signaling pathway. This leads to increased glucose uptake by cells, particularly in muscle and adipose tissue, and inhibits hepatic glucose production, thereby lowering blood glucose levels.

Mechanism

Signalweg

Insulin glargine acts primarily through the insulin receptor (IR), initiating signaling via the insulin receptor substrate (IRS) pathway, which activates the PI3K/Akt pathway and the MAPK pathway, leading to enhanced glucose uptake, glycogen synthesis, and inhibition of gluconeogenesis. This results in a sustained reduction in blood glucose levels due to its long-acting, peakless profile, which mimics basal insulin secretion. The precise molecular mechanisms underlying its prolonged action compared to other insulins are not fully understood, but they may involve its unique amino acid modifications that alter its pharmacokinetics.

Half-Life & Pharmacokinetics

SCSubcutaneous

No defined half-life; provides steady insulin levels over 24 hours

Insulin glargine is designed for subcutaneous use and provides a peakless, prolonged action profile.

Storage

Temperature

Refrigerate at 2-8C

Light

Protect from light

Form

Aqueous solution: use within 28 days after opening

Notes

Do not freeze; discard if frozen.

Solubility

Löslichkeit

Soluble in water, formulated as an aqueous solution for injection.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not a controlled substance under BtMG.

🇺🇸US

FDA approved; prescription required.

🇦🇺AU

TGA S4 (Prescription Only Medicine).

🇬🇧UK

POM (Prescription Only Medicine); regulated by MHRA.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the long-term safety and efficacy of insulin glargine in diverse populations, particularly in those with concurrent diseases or comorbidities, as highlighted by the study in diabetic dogs. Further research is needed to explore the pharmacokinetic variability of insulin glargine among different individuals and the implications of this variability on dosing regimens and hypoglycemia risk. Additionally, larger randomized controlled trials (RCTs) are necessary to assess the immunogenicity of insulin glargine formulations in various demographic groups and their potential impact on clinical outcomes.

70 Research Publications

1,213

Total Citations

41

Human/RCT

2.0

Avg. Influence

2024

Latest

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#01

Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study).

HumanInfluence7.0
100
The study demonstrated that LY2963016 insulin glargine provided comparable efficacy and safety to Lantus® in human patients with type 2 diabetes over 24 weeks.
#02

Evaluation of the carcinogenic potential of insulin glargine (LANTUS) in rats and mice.

AnimalInfluence7.0
97
Researchers observed no systemic carcinogenic potential of insulin glargine in rats and mice, despite some rodent-specific injection site reactions.
#03

Evaluation of the reproductive toxicity and embryotoxicity of insulin glargine (LANTUS) in rats and rabbits.

AnimalInfluence1.0
84
Researchers observed that insulin glargine had no significant reproductive or embryotoxic effects in rats, with toxicity linked to hypoglycemia at high doses.
#04

Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial.

HumanInfluence1.0
72
Researchers observed significant reductions in HbA1c with low hypoglycemia risk when initiating insulin glargine therapy in human patients with type 2 diabetes on oral antidiabetic agents.
#05

No evidence for accumulation of insulin glargine (LANTUS): a multiple injection study in patients with Type 1 diabetes.

HumanInfluence1.0
68
The study demonstrated that there is no evidence of accumulation of insulin glargine after multiple injections in human patients with Type 1 diabetes.
#06

Effect of therapy with insulin glargine (lantus) on glycemic control in toddlers, children, and adolescents with diabetes.

Case ReportInfluence1.0
56
Researchers observed a significant reduction in HbA1c and hypoglycemia frequency in children and adolescents with diabetes after starting insulin glargine therapy, without increasing BMI or insulin requirements.
#07

Therapy with insulin glargine (Lantus) in toddlers, children and adolescents with type 1 diabetes.

HumanInfluence3.0
45
Researchers observed that insulin glargine significantly improved metabolic control in children and adolescents with type 1 diabetes without increasing severe hypoglycemic events.
#08

Insulin glargine in the treatment of type 1 and type 2 diabetes.

ReviewInfluence1.0
44
The review indicated that insulin glargine provides consistent plasma insulin levels and lower rates of hypoglycemia compared to traditional basal insulins in human patients with type 1 and type 2 diabetes.
#09

Insulin glargine: long-acting basal insulin analog for improved metabolic control.

ReviewInfluence4.0
40
The review indicated that insulin glargine effectively mimics normal insulin secretion patterns, providing improved metabolic control with a better safety profile than traditional human insulins.
#10

Insulin glargine (Lantus).

Owens D R & Griffiths S · International journal of clinical practice · 2002

Review
38
The study demonstrated that insulin glargine provides equivalent glycemic control to NPH insulin with a lower risk of hypoglycemia and higher treatment satisfaction in patients with type 1 and type 2 diabetes.

Key findings

  1. 01Insulin glargine offers consistent insulin levels without peaks, reducing the risk of low blood sugar.
  2. 02Patients using insulin glargine reported better fasting blood glucose levels and overall treatment satisfaction.
  3. 03It can be effectively combined with other insulin types or oral medications for better diabetes management.

Clinical Trials (53)

Preclinical
Phase I
Phase II
Phase III
Approved

53

Total Trials

31,662

Total Enrolled

Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

NCT03703869COMPLETED
Sponsor

Sanofi

Enrollment

4,589

Started

2018

Primary outcome

Change in HbA1c at month 6

Diabetes

Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)

NCT00390728Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

2,346

Started

2002

Primary outcome

Main study: Frequency of severe hypoglycaemia

Diabetes Mellitus, Type 1

The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

NCT00279201Phase 4COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

2,091

Started

2005

Primary outcome

INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)

Diabetes Mellitus, Type 2

Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

NCT00174824Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

1,024

Started

2001

Primary outcome

The percentage of patients with a 3-step or greater progression in the patient

Diabetes Mellitus, Type 2

Insulin Glargine "All to Target" Trial

NCT00384085Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

588

Started

2006

Primary outcome

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)

Diabetes Mellitus, Type 2

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

NCT00469092Phase 4COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

480

Started

2007

Primary outcome

Glycosylated Haemoglobin A1c (HbA1c)

DiabetesDiabetes Mellitus, Type 2

This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

NCT00418522Phase 4COMPLETED
Sponsor

Pfizer

Enrollment

413

Started

2007

Primary outcome

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

Diabetes Mellitus, Type 2

Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

NCT04075513Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

343

Started

2019

Primary outcome

Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis

Type 1 Diabetes Mellitus

Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes

NCT00191464Phase 4COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

320

Started

2003

Primary outcome

HbA1C

Diabetes Mellitus, Type 2

Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali

NCT06624943Phase 4COMPLETED
Sponsor

Life for a Child Program, Diabetes Australia

Enrollment

260

Started

2022

Primary outcome

HbA1c

Type 1 Diabetes (T1D)

Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

NCT04980027Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

228

Started

2021

Primary outcome

Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

Type 2 Diabetes Mellitus

The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes

NCT06127433Phase 4UNKNOWN
Sponsor

Sun Yat-sen University

Enrollment

210

Started

2023

Primary outcome

Intergroup remission rate at 24 week

Insulin Pump,Continuous Glucose Monitoring Technology

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga

NCT02561130Phase 4COMPLETED
Sponsor

Population Health Research Institute

Enrollment

154

Started

2015

Primary outcome

Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group

Type 2 Diabetes Mellitus

Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

NCT05114590Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

124

Started

2022

Primary outcome

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

Type 2 Diabetes Mellitus

A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

NCT06716424Phase 4ACTIVE_NOT_RECRUITING
Sponsor

Sanofi

Enrollment

105

Started

2025

Primary outcome

Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)

Type 2 Diabetes

Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

NCT00539448Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

98

Started

2007

Primary outcome

Evaluating the Glycemic control of the regimen : Change in A1C levels

Diabetes Mellitus, Type 1

JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients

NCT01269996Phase 4COMPLETED
Sponsor

Chinese University of Hong Kong

Enrollment

71

Started

2011

Primary outcome

To evaluate the treatment efficacy

Type 2 Diabetes Mellitus

Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes

NCT00191178Phase 4COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

60

Started

2003

Primary outcome

Compare twice-daily insulin lispro Low Mix therapy and once-daily insulin glargine therapy with respect to perceived mood on patient-rated questionnaires following chronic treatment administration in patients with type 2 diabetes

Type 2 Diabetes

Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

NCT00609856Phase 4COMPLETED
Sponsor

Skane University Hospital

Enrollment

36

Started

2004

Primary outcome

Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity

Type 2 DiabetesSecondary Drug Failure

Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards

NCT01594060Phase 4COMPLETED
Sponsor

HaEmek Medical Center, Israel

Enrollment

36

Started

2012

Diabetes Mellitus Type 2

Lantus Effect on Myocardial Glucose Metabolism in T2

NCT00335465Phase 4COMPLETED
Sponsor

Sanofi

Enrollment

15

Started

2005

Primary outcome

effect of insulin treatment on myocardial function, perfusion and glucose metabolism.

Diabetes Mellitus, Type 2

Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

NCT00627471Phase 4TERMINATED
Sponsor

Sanofi

Enrollment

9

Started

2008

Primary outcome

Mean difference in HbA1c (efficacy)

Type 2 Diabetes

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

NCT01959529Phase 3COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

7,637

Started

2013

Primary outcome

Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

DiabetesDiabetes Mellitus, Type 2

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

NCT02058147Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

1,170

Started

2014

Primary outcome

Change in HbA1c From Baseline to Week 30

Type 2 Diabetes

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

NCT00755287Phase 3COMPLETED
Sponsor

Hoffmann-La Roche

Enrollment

1,072

Started

2008

Primary outcome

Absolute change from baseline in HbA1c

Diabetes Mellitus Type 2

A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

NCT01682759Phase 3COMPLETED
Sponsor

Merck Sharp & Dohme LLC

Enrollment

751

Started

2012

Primary outcome

Change From Baseline in Hemoglobin A1C at Week 54

Type 2 Diabetes Mellitus

Randomized Sitagliptin Withdrawal Study (MK-0431-845)

NCT02738879Phase 3COMPLETED
Sponsor

Merck Sharp & Dohme LLC

Enrollment

746

Started

2016

Primary outcome

Change From Baseline in A1C at Week 30

Type 2 Diabetes Mellitus

Gan & Lee Insulin Glargine Target Type (2) Evaluating Research

NCT03371108Phase 3COMPLETED
Sponsor

Gan and Lee Pharmaceuticals, USA

Enrollment

567

Started

2017

Primary outcome

Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint

Diabetes Mellitus, Type 2

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

NCT01952145Phase 3COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

557

Started

2013

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

DiabetesDiabetes Mellitus, Type 2

Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

NCT00355849Phase 3COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

555

Started

2006

Primary outcome

To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.

Diabetes Mellitus, Type 2

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

NCT01045707Phase 3COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

530

Started

2010

Primary outcome

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

DiabetesDiabetes Mellitus, Type 2

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

NCT02752828Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

521

Started

2016

Primary outcome

Change from baseline in HbA1c

Type 2 Diabetes Mellitus

Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

NCT02294474Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

505

Started

2015

Primary outcome

Change in HbA1c From Baseline to Week 26

Type 2 Diabetes Mellitus

Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

NCT03798080Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

426

Started

2019

Primary outcome

Change in HbA1c

Type 2 Diabetes Mellitus

Insulin Glargine Combination Therapies in Type II Diabetics

NCT00783744Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

375

Started

2001

Primary outcome

Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %

Diabetes Mellitus, Type 2

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

NCT01584232Phase 3COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

361

Started

2012

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Type 2 Diabetes Mellitus

Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

NCT00097084Phase 3COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

324

Started

2004

Primary outcome

HbA1c

DiabetesDiabetes Mellitus, Type 2

Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

NCT03434119Phase 3TERMINATED
Sponsor

Sanofi

Enrollment

241

Started

2018

Primary outcome

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Type 2 Diabetes Mellitus

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

NCT00046462Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

240

Started

2001

Primary outcome

To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy

Diabetes Mellitus

Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

NCT00437112Phase 3COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

142

Started

2007

Primary outcome

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.

Diabetes Mellitus, Type 2

20 Week Bridging Study in Type II DM

NCT00563225Phase 3COMPLETED
Sponsor

Sanofi

Enrollment

90

Started

2002

Primary outcome

To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Diabetes Mellitus Type II

Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon

NCT00694122Phase 3COMPLETED
Sponsor

Massachusetts General Hospital

Enrollment

27

Started

2005

Primary outcome

Blood Glucose Area Under the Curve (AUC)

Type 1 DiabetesDawn Phenomenon

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

NCT00612040Phase 2COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

178

Started

2008

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)

DiabetesDiabetes Mellitus, Type 1

Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

NCT02470039Phase 2COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

50

Started

2015

Primary outcome

Change in fasting plasma glucose (FPG)

DiabetesDiabetes Mellitus, Type 2

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

NCT04236895Phase 1COMPLETED
Sponsor

Gan and Lee Pharmaceuticals, USA

Enrollment

114

Started

2018

Primary outcome

PK endpoint

Diabetes Mellitus, Type 1

A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

NCT03965013Phase 1COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

78

Started

2019

Primary outcome

Number of treatment-emergent adverse events

Diabetes Mellitus, Type 1Healthy Volunteers

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

NCT02220296Phase 1COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

62

Started

2014

Primary outcome

Incidence of adverse events

HealthyDiabetesDiabetes Mellitus, Type 1

A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine

NCT01704417Phase 1COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

40

Started

2012

Primary outcome

BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise

DiabetesDiabetes Mellitus, Type 1

A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes

NCT04136067Phase 1COMPLETED
Sponsor

Novo Nordisk A/S

Enrollment

36

Started

2019

Primary outcome

Number of treatment-emergent adverse events (AEs)

Diabetes Mellitus, Type 2

A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements

NCT02152384Phase 1COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

28

Started

2014

Primary outcome

Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro

Diabetes Mellitus, Type 1

A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics

NCT02197520Phase 1COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

24

Started

2014

Primary outcome

Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

Diabetes Mellitus, Type 2

A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

NCT01771250Phase 1COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

15

Started

2013

Primary outcome

Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

Diabetes Mellitus, Type 1

Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens

NCT02587741Early Phase 1UNKNOWN
Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

600

Started

2015

Primary outcome

The incidence of diabetic retinopathy

Diabetic Retinopathy

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This page is for informational and research purposes only. All information is based on published scientific literature and does not constitute medical advice, diagnosis, or treatment recommendations. Many substances listed may not be approved for human use and may be subject to drug regulation laws (e.g., AMG in Germany, FDA in the US). PepStack does not encourage the use of any substance on humans. Always consult a qualified healthcare professional before making any health-related decisions. Use of this information is entirely at your own risk. PepStack assumes no liability for the accuracy, completeness, or timeliness of the content provided. Full disclaimer