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Insulin Glargine 300 Units Ml

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Important Safety Information For Soliqua 100/33 100 Units/ml And 33 Mcg/ml

Insulin glargine 300 U/mL reduces the risk of hypoglycaemia while achieving good glycaemic control

What is the most important information I should know about SOLIQUA 100/33?

Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder , or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.

Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33?

Do not use SOLIQUA 100/33 if you:

  • are having an episode of low blood sugar
  • are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

How should I use SOLIQUA 100/33?

What are the possible side effects of SOLIQUA 100/33?

Comparison Of Insulin Glargine 300 Units/ml And 100 Units/ml In Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles And Variability Using Morning Or Evening Injections

Diabetes Care

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  • Richard M. Bergenstal, Timothy S. Bailey, David Rodbard, Monika Ziemen, Hailing Guo, Isabel Muehlen-Bartmer, Andrew J. Ahmann Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care 1 April 2017 40 : 554560.

    The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL or glargine 100 units/mL in the morning or evening, in combination with mealtime insulin.

    In this 16-week, exploratory, open-label, parallel-group, two-period crossover study , 59 adults with type 1 diabetes were randomized to once-daily Gla-300 or Gla-100 given in the morning or evening . The primary efficacy end point was the mean percentage of time in the target glucose range , as measured using continuous glucose monitoring , during the last 2 weeks of each 8-week period. Additional end points included other CGM glycemic control parameters, hypoglycemia , and adverse events.

    Less increase in CGM-based glucose levels in the last 4 h of the 24-h injection interval, smoother average 24-h glucose profiles irrespective of injection time, and reduced nocturnal hypoglycemia were observed with Gla-300 versus Gla-100.

    Important Safety Information For Soliqua 100/33 Injection 100 Units/ml And 33 Mcg/ml

    What is the most important information I should know about SOLIQUA 100/33?

    Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

    SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

    Before using SOLIQUA 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder , or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.

    Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

    Who should not use SOLIQUA 100/33?

    Do not use SOLIQUA 100/33 if you:

    • are having an episode of low blood sugar
    • are allergic to insulin glargine, lixisenatide, or any of the ingredients in SOLIQUA 100/33. Symptoms of a severe allergic reaction with SOLIQUA 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

    Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions, including if you:

    How should I use SOLIQUA 100/33?

    What are the possible side effects of SOLIQUA 100/33?

    Recommended Reading: How Much Insulin Should I Take

    New Insulin Glargine 300 Unitsml1 Provides A More Even Activity Profile And Prolonged Glycemic Control At Steady State Compared With Insulin Glargine 100 Unitsml1

    Diabetes Care

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  • Reinhard H.A. Becker, Raphael Dahmen, Karin Bergmann, Anne Lehmann, Thomas Jax, Tim Heise New Insulin Glargine 300 Units·mL1 Provides a More Even Activity Profile and Prolonged Glycemic Control at Steady State Compared With Insulin Glargine 100 Units·mL1. Diabetes Care 1 April 2015 38 : 637643.

    To characterize the pharmacokinetics and pharmacodynamics of a new insulin glargine comprising 300 units·mL1 , compared with insulin glargine 100 units·mL1 at steady state in people with type 1 diabetes.

    A randomized, double-blind, crossover study was conducted, applying the euglycemic clamp technique over a period of 36 h. In this multiple-dose to steady-state study, participants received once-daily subcutaneous administrations of either 0.4 or 0.6 units·kg1 Gla-300 for 8 days in one treatment period and 0.4 units·kg1 Gla-100 for 8 days in the other. Here we focus on the results of a direct comparison between 0.4 units·kg1 of each treatment. PK and PD assessments performed on the last treatment day included serum insulin measurements using a radioimmunoassay and the automated euglycemic glucose clamp technique over 36 h.

    Gla-300 provides more even steady-state PK and PD profiles and a longer duration of action than Gla-100, extending blood glucose control well beyond 24 h.

    Slight Differences In Weight Gain

    Toujeo Solostar (Insulin Glargine) 300 IU/ml, 5 x 1.5

    Over the initial 6-month trial period, patients with type 1 diabetes who received Gla-300 generally gained slightly less weight than those who received Gla-100 .13,19 This statistically significant difference was lost at 12 months.14

    During the 12-month trial period, for people with type 2 diabetes treated with Gla-300, significantly less weight gain was observed compared with those treated with Gla-100 .18

    Also Check: How To Lower Blood Sugar Immediately Without Insulin

    Data Analysis And Statistics

    No formal sample size estimation was performed for this first-of-its-kind head-to-head comparison of basal insulins using CGM in a crossover exploratory study. Assuming a 15% withdrawal rate, we planned to enroll approximately 56 participants to achieve 48 evaluable participants.

    Unless otherwise specified, the efficacy results were analyzed using CGM data from the last 2 weeks of each treatment period by treatment group overall some end points were also analyzed by treatment group and injection schedule .

    The modified intent-to-treat population included all randomized participants who received at least one dose of study medication and had at least one efficacy assessment after the baseline. The primary efficacy population included all participants from the mITT population who had evaluable CGM data after the baseline. The safety population was defined as all randomized participants who received at least one dose of study medication.

    Post Hoc Analyses

    To confirm the more stable and prolonged duration of the glucose-lowering activity of Gla-300, the mean and SD of the change per participant in CGM-based glucose level in the last 4 h of the 24-h injection interval was calculated for the last 2 weeks of each treatment period, compared between Gla-300 and Gla-100 overall , and described by treatment group for morning and evening injections .

    Study Design And Treatment

    This was a single-center, randomized, double-blind, two-treatment, two-period, two-sequence crossover study in two parallel cohorts, evaluating two dose levels of Gla-300, with a standard dose of Gla-100 as an active control, in 30 participants with type 1 diabetes . In cohort 1 participants received, in randomized treatment order, Gla-300 0.4 units·kg1·day1 in the first treatment period and Gla-100 0.4 units·kg1·day1 in the second or vice versa. In cohort 2, participants received Gla-300 0.6 units·kg1·day1 or Gla-100 0.4 units·kg1·day1. Each treatment was administered subcutaneously at a periumbilical site, using a 1 mL syringe with 1 unit per 10 µL graduation .

    The total insulin dose was rounded to the nearest unit, meaning that the integer dose could be accurately administered using the graduation marks for Gla-100. If not exactly divisible by 3, the Gla-300 dose needed to be rounded to the nearest graduation mark . This resulted in either no difference or exactly 1 unit difference between the injected individual Gla-100 and Gla-300 doses, e.g., 27, 28, and 29 units of Gla-100 corresponded to 27, 27, and 30 units of Gla-300.

    The dose on day 8 of each treatment period was followed by a 36-h euglycemic clamp. An initial in-house period over 3 nights was followed by 4 outpatient days and a final in-house period from the morning of day 8 to end of the clamp. There was a washout period of 519 days between consecutive treatment periods.

    Also Check: Ways To Take Insulin For Type 1 Diabetes

    How Does It Compare

    The safety and efficacy of Gla-300 was compared with that of Gla-100 only. There are no data on the comparative efficacy of Gla-300 and other diabetes medicines.

    A number of Phase 3 head-to-head clinical trials have been published comparing Gla-300 with Gla-100 in patients with type 1 diabetes13,14 and in patients with type 2 diabetes.15-18 Trials included an initial 6-month treatment period followed by a 6-month extension period.

    Patients in all trials were aged 18 years or over, with a baseline HbA1c of 5386 mmol/mol for those with type 1 diabetes, and 5397 mmol/mol for those with type 2 diabetes.13-18

    In all trials, basal insulin was administered once daily.

    The dose was generally titrated once weekly and no more than every 3 to 4 days, aiming for a fasting self-monitored plasma glucose target of 4.47.2 mmol/L in the type 1 diabetes trials13,14 and 4.45.6 mmol/L in the type 2 diabetes trials.15-18 Cessation of titration was left to the individual judgement of the investigators and participants.15

    All trials were open label because the two glargine solutions were administered using different injection devices. The potential for biased safety and efficacy outcomes due to lack of blinding cannot be excluded.

    Insulin Glargine Conc 300 Unit/ml Subcutaneous Pen

    Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Patients with T2D

    The photos shown are samples onlyNot all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.close popup

    Insulin glargine 300 units/ml pen – injection

    Pronunciation

    Insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

    Insulin glargine is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar get into cells so your body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

    Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

    This insulin product is a concentrated form of standard insulin . Learn all preparation and usage instructions from your health care professional and the product package. Check that you are using the correct insulin before injecting this medication.

    In the US –

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    Efficacy And Safety Of Insulin Glargine 300 Units/ml Versus Insulin Glargine 100 Units/ml In Children And Adolescents With Type 1 Diabetes: Results Of The Edition Junior Randomized Controlled Trial

    Diabetes Care

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  • Thomas Danne, William V. Tamborlane, Oleg A. Malievsky, Denise R. Franco, Tomoyuki Kawamura, Marek Demissie, Elisabeth Niemoeller, Harmonie Goyeau, Marek Wardecki, Tadej Battelino Efficacy and Safety of Insulin Glargine 300 Units/mL Versus Insulin Glargine 100 Units/mL in Children and Adolescents With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care 1 July 2020 43 : 15121519.

    To compare efficacy and safety of insulin glargine 300 units/mL and 100 units/mL in children and adolescents with type 1 diabetes.

    EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90130 mg/dL , with continuation of prior prandial insulin. The primary end point was change in HbA1c from baseline to week 26. Other assessments included change in fasting plasma glucose , hypoglycemia, hyperglycemia with ketosis, and adverse events.

    Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.

    How Is This Medicine Best Taken

    Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

    What do I do if I miss a dose?

    • Take a missed dose as soon as you think about it.
    • If it is close to the time for your next shot, skip the missed shot and go back to your normal time.
    • Do not take 2 doses at the same time or extra doses.
    • If you are not sure what to do if you miss a dose, call your doctor.

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    Similar Efficacy To That Of Gla

    Toujeo (insulin glargine 300 units/mL) DoubleStar  New ...

    Over 12 months Gla-300 provided comparable blood glucose control to that of Gla-100 for people with type 1 diabetes, as measured by HbA1c levels:14

    • mean reduction in HbA1c was 0.20% for Gla-300 and 0.22% for Gla-100.

    Patient-level meta-analysis of the pivotal Phase 3 trials for people with type 2 diabetes showed that treatment with Gla-300 or Gla-100 over 12 months was associated with:

    • a mean reduction in HbA1c from baseline of 0.91% for Gla-300 and 0.80 % for Gla-10018,19 20,21
    • a least squares mean between-group difference from baseline of 0.10 % or 1.09 mmol/mol p = 0.0174 .

    At 12-month follow-up, a slightly higher dose of Gla-300, compared with Gla-100, was needed to maintain similar control of blood sugar levels:

    • type 1 diabetes: 15.6% higher dose13,14
    • type 2 diabetes: 14% higher dose.18,19

    The cause of the higher dose requirement might be due to a slight decrease in the bioavailability of Gla-300.15,19 It is speculated that Gla-300 resides in the subcutaneous space longer than Gla-100, which leads to a larger amount of the insulin being inactivated by tissue peptidases at the injection site.15,19

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    Significance Of This Study

    What is already known about this subject?

    • Hospitalization is an opportunity to evaluate the metabolic situation of insufficiently controlled patients with type 2 diabetes and to intensify their antidiabetic treatment at discharge.

    • Glargine 300U/mL is a basal insulin analog that results in more even pharmacokinetic and pharmacodynamic profiles compared with insulin glargine 100U/mL, which translates into similar glycosylated hemoglobin reductions and less hypoglycemic events with once-daily subcutaneous injections.

    What are the new findings?

    • The use of Gla-300 during hospitalization and therapy intensification at discharge in hospitalized people with type 2 diabetes insufficiently controlled with basal insulin and/or non-insulin antidiabetic drugs significantly improved their glycemic status, reaching HbA1c levels close to 7%, with an adequate safety profile and a high degree of treatment satisfaction 6months after the hospital discharge.

    How might these results change the focus of research or clinical practice?

    • Gla-300 can be a treatment choice for hospital and postdischarge diabetes management when type 2 diabetes is insufficiently controlled with other basal insulin and/or non-insulin antidiabetic medication.

    Switching From Other Basal Insulin

    • From a once-daily insulin: start with a unit-for-unit dose of the basal insulin being discontinued.5
    • From a twice-daily basal insulin: start with 80% of the total daily dose of the basal insulin being discontinued.5

    When changing from one basal insulin to another, the dosage of short-acting or very short-acting insulin and oral diabetes medicines may also need to be adjusted.10

    Close monitoring of blood glucose is also recommended during the change and in the following weeks.10

    Read Also: Max Sugar Per Day For Diabetics

    Adverse Events And Insulin Antibodies

    The number of participants with any treatment-emergent AE was similar in the Gla-300 and Gla-100 groups . A comparable number of participants experienced injection site reactions in the Gla-300 group and in the Gla-100 group . Three participants in each treatment group withdrew from the study due to TEAEs. The number of participants with serious TEAEs was also similar between groups , with no signal for any type of event being different . One participant in the Gla-300 group, with preexisting cardiovascular disease, died of a cardiac event during the 6-month treatment period.

    When analyzed by number of participants, those insulin antibody positive, number with cross-reacting insulin antibodies, median antibody titer, upper quartile, maximum level, and at baseline, week 4, week 12, month 6 and for the entire study period, no signal of differences between Gla-300 and Gla-100 groups was detectable .

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