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Real World Glycemic Effectiveness of Linagliptin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338803
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Linagliptin

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Study Type : Observational
Actual Enrollment : 11001 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real World Glycemic Effectiveness of Linagliptin Among Type 2 Diabetes Mellitus Adults by Age and Renal Function
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : February 2, 2018
Actual Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
Drug Information available for: Linagliptin

Group/Cohort Intervention/treatment
Patients with a written prescription for linagliptin Drug: Linagliptin
drug
Other Name: ONDERO, TRAJENTA, TRAYENTA, TRAZENTA, TRADJENTA




Primary Outcome Measures :
  1. Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories [ Time Frame: Baseline and 60 to 180 days ]

    Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).

    Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date.


  2. Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories [ Time Frame: Baseline and 60 to 180 days ]

    Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories.

    Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter^2 and eGFR not available).



Secondary Outcome Measures :
  1. Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories [ Time Frame: 60 to 180 days ]
    Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).

  2. Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories [ Time Frame: 60 to 180 days ]
    Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter^2 and eGFR not available).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectivenes
Criteria

Inclusion Criteria:

  • ≥ 1 written prescription for linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®)in the EHR (electronic health record) data during the identification period
  • ≥ 40 years of age based on the year of the index date
  • First active date in the EHR is ≥ 180 days prior to the index date
  • ≥ 1 diagnosis code representing Type 2 diabetes (T2DM) in the EHR data during the 180-day pre-index period or on the index date
  • ≥ 1 HbA1c value during the 180-day pre-index period or on the index date
  • ≥ 1 HbA1c value 60 to 180 days after the index date

Exclusion Criteria:

  • ≥ 1 written prescription, medication administration or medication history record for linagliptin or other dipeptidyl peptidase (DPP-4) inhibitor in the EHR data during the 180-day pre-index period
  • ≥ 1 written prescription or medication administration for a new antihyperglycemic medication other than linagliptin on the index date New antihyperglycemic medication will be defined as a written prescription or medication administration for any antihyperglycemic medication that was not present in the patient's written prescription, medication administration, or medication history records during the 180-day pre-index period.

Individual antihyperglycemic medications will be distinguished by generic name using the column labelled "Medication Name" in Tables 2 through 13. Combination products containing two generic ingredients will be considered as two distinct antihyperglycemic medications Note: This exclusion criterion is designed to exclude patients from the study sample if they start a new antihyperglycemic medication other than linagliptin on the index date. Patients that start a new antihyperglycemic medication in the follow-up period will not be removed from the study sample to avoid creating a biased sample. Addition of a new antihyperglycemic medication during follow-up will be evaluated through the sensitivity analysis described in Section 9.7.4.4. While we will be capturing additions of new therapies, discontinuation of linagliptin is not able to be accurately measured in electronic record data. The electronic record data capture prescriptions written by a prescriber, but it is not possible to know if patients received and adhered to their medication and there are no structured data fields to identify if and when a medication was discontinued by the patient or the provider

  • ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ transplant, or bone marrow transplant in the EHR data during the 180-day pre-index period or on the index date
  • ≥ 1 diagnosis code representing malignancy in the EHR data during the 180-day preindex period or on the index date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338803


Locations
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United States, Minnesota
Optum
Eden Prairie, Minnesota, United States, 55344
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03338803    
Other Study ID Numbers: 1218-0182
First Posted: November 9, 2017    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action