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Lantus (Insulin Glargine) - Summary

 



LANTUS SUMMARY

LANTUS®
(insulin glargine [rDNA origin] injection)

LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain.

LANTUS is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.


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NEWS HIGHLIGHTS

Media Articles Related to Lantus (Insulin Glargine)

Canadian study demonstrates new approach to achieving diabetes control
Source: The Doctors Lounge - Endocrinology and Diabetes
The INSIGHT study demonstrates early addition of insulin glargine therapy safely achieved better glycemic than adding oral agents.

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Published Studies Related to Lantus (Insulin Glargine)

Evaluation of exenatide vs. insulin glargine in type 2 diabetes: cost-effectiveness analysis in the German setting. [2009.11]
OBJECTIVES: The objective of this analysis was to determine the cost-effectiveness of exenatide vs. insulin glargine in patients with type 2 diabetes failing to achieve glycaemic control with oral antidiabetic agents, in the German setting, from a third-party payer perspective... CONCLUSIONS: Exenatide was projected to be associated with similar clinical outcomes and increased costs compared with insulin glargine. Analysis of cost-effectiveness from a third-party perspective suggests that exenatide is likely to represent good value for money in the German setting.

Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. [2009.10.12]
Abstract Objectives: To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs. Research design and methods: In this 26-week, open-labeled, randomized, parallel-group, multinational, treat-to-target trial, 480 insulin-naive subjects were randomized to receive either BIAsp 30 before dinner or insulin glargine at bedtime, both in combination with metformin and glimepiride.

Effects of initiating insulin and metformin on glycemic control and inflammatory biomarkers among patients with type 2 diabetes: the LANCET randomized trial. [2009.09.16]
CONTEXT: As diabetes is in part an inflammatory condition, the initiation of insulin and/or metformin may beneficially reduce levels of inflammatory biomarkers such as high-sensitivity C-reactive protein (hsCRP). OBJECTIVE: To determine whether insulin alone or combined with metformin lowers levels of hsCRP, IL-6, and soluble tumor necrosis factor receptor 2 (sTNFr2) in patients with recent-onset type 2 diabetes mellitus... CONCLUSION: In patients with recent-onset type 2 diabetes, treatment with insulin or metformin compared with placebo did not reduce inflammatory biomarker levels despite improving glucose control. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00366301.

Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial. [2009.09]
BACKGROUND: Patients with type 1 diabetes require intensive insulin therapy for optimal glycemic control. AIR((R)) inhaled insulin (system from Eli Lilly and Company, Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) may be an efficacious and safe alternative to subcutaneously injected (SC) mealtime insulin... CONCLUSIONS: The AIR inhaled insulin program was terminated by the sponsor prior to availability of any Phase 3 data for reasons unrelated to safety or efficacy. Despite early termination, this trial provides evidence that AIR insulin was less efficacious in lowering A1C and was associated with a greater decrease in DL(CO) and increased incidence of cough than SC insulin in patients with type 1 diabetes.

Exenatide versus insulin glargine: a cost-effectiveness evaluation in patients with Type 2 diabetes in Switzerland. [2009.08]
OBJECTIVES: To investigate the long-term clinical and economic outcomes associated with exenatide versus insulin glargine as "add-on" treatments to oral therapy in individuals with Type 2 diabetes inadequately controlled with combination oral agents in the Swiss setting... CONCLUSIONS: Exenatide was associated with comparable life expectancy and an improvement in quality-adjusted life expectancy versus insulin glargine over a 35-year time horizon. Based on current standards exenatide would be a cost-effective treatment alternative to insulin glargine in Switzerland for Type 2 diabetes patients inadequately controlled on oral therapy.

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Clinical Trials Related to Lantus (Insulin Glargine)

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) [Completed]
Primary objective:

AT. LANTUS main study*

- To determine the optimal treatment algorithm for insulin glargine based on the incidence

of severe hypoglycaemia.(*Target Number of patients for the main study: 2346)

HALT Sub-study**

- To test the hypothesis that titration regimens involving insulin glargine are associated

with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetes.(**Target Number of patients for the Sub-study: 250)

Secondary objectives:

AT. LANTUS main study

To determine:

- the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each

treatment regimen

- the difference in glycemic control as measured by HbA1c and fasting blood glucose with

each treatment regimen

- the difference in glycemic control as measured by HbA1c and fasting blood glucose

between baseline and end of treatment

- the safety on the use of insulin glargine in each treatment algorithm

- the change in subject weight with each treatment regimen

- the change in insulin doses with each treatment regimen

- the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction

Questionnaire, sub-study only) with each treatment regimen

HALT Sub-study (baseline to study end)

- To estimate the relationship between change in HbA1c and incidence of hypoglycaemia

- To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to

incidence of hypoglycaemia

- To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale

(HADS) in relation to the incidence of hypoglycaemia

- To examine the use of the Prescription Plan versus standard management (no Prescription

Plan)

Lantus in Prediabetes [Completed]

Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus [Completed]
To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil) [Completed]
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

AT.LANTUS: A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus [Completed]
Primary objective:

- To determine the optimal treatment algorithm for the clinical use of insulin glargine

based on the incidence of severe hypoglycaemia.

Secondary objectives:

- To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and

nocturnal hypoglycaemia.

- To determine the difference in glycaemic control as measured by HbA1c and fasting blood

glucose between the treatment algorithms.

- To determine the difference in glycaemic control as measured by HbA1c and fasting blood

glucose between baseline and end of treatment.

- To obtain safety data on the use of insulin glargine in each treatment algorithm.

- To measure change in subject weight and insulin dose between baseline and end of

treatment.

- To determine subject quality of life and treatment satisfaction (sub-study)

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Lantus has an overall score of 9. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Lantus review by 27 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Insulin Dependent Diabetes Mellitus
Dosage & duration:   45 units per day (dosage frequency: twice a day) for the period of four years, still on going
Other conditions:   None
Other drugs taken:   Insulin Lispro
  
Reported Results
Benefits:   I experienced markedly improved fasting blood glucose levels, and greater stability of blood sugar before and after meals. I had found with other treatment options, such as the insulin pump and the nph insulins that my morning blood sugars were always high, even with increased dosages.
Side effects:   The only side effects were increased weight gain and increased hypoglycemia in the late evenings/early mornings. The side effect is because Lantus has a 22 hour duration after injection and as a result whenever I experience a greater than usual amount of activity, my insulin sensitivity increases dramatically.
Comments:   Treatment consisted of a morning and evening dose of lantus split up as 30 units in the evening and 15 units in the morning. It took approximately two years of playing with the dosage amounts to find this as the "best fit" as all dosages either resulted in extremely low evening blood sugars or extremely high morning blood sugars. Also, changes in activity result in severe blood sugar swings as well.

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Page last updated: 2009-10-20

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