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Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration

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ClinicalTrials.gov Identifier: NCT03764631
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with T2DM initiating Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Empagliflozin Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
subjects with Type 2 Diabetes mellitus Drug: Empagliflozin
Drug

Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Dipeptidyl-peptidase 4 - Drug




Primary Outcome Measures :
  1. subjects with incidence of Ketoacidosis [ Time Frame: Up to 12 months ]
  2. subjects with incidence of severe urinary tract infections [ Time Frame: Up to 12 months ]
  3. subjects with incidence of volume depletion [ Time Frame: Up to 12 months ]
  4. subjects with incidence of dehydration [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. subjects with risk of ketoscidosis in The Ramadan period [ Time Frame: Up to day 29 ]
    1st day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar)

  2. subjects with risk of severe urinary tract infections in The Ramadan period [ Time Frame: Up to day 29 ]
    1st day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar)

  3. subjects with risk of volume depletion in The Ramadan period [ Time Frame: Up to day 29 ]
    1st day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar)

  4. subjects with risk of dehydration in The Ramadan period [ Time Frame: Up to day 29 ]
    1st day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Main diagnosis for study entry

-Patients diagnosed with T2DM will be included.

Criteria

Inclusion Criteria:

  • Patients who have signed Informed consent form.
  • The patients will be at least 18 years old at index date, diagnosed with Type 2 diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous 12 months.

Exclusion Criteria:

  • Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of their excipients
  • Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated according Saudi Food and Drug Authority (SFDA) approved label
  • Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors will be excluded.
  • The same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.

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): NCT03764631


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Saudi Arabia
Abha International Private Hospital Recruiting
Abha, Saudi Arabia, 61431
DAFA Special Polyclinic Recruiting
Jeddah, Saudi Arabia, 21214
Ghassan Najeeb Pharaon Hospital Recruiting
Jeddah, Saudi Arabia, 21412
Dr.Bakhsh Hospital Recruiting
Jeddah, Saudi Arabia, 21452
Saudi German Hospital Recruiting
Jeddah, Saudi Arabia, 21461
Al Abeer Medical Center Recruiting
Jeddah, Saudi Arabia, 21573
Al-Abeer Medical Center Recruiting
Jeddah, Saudi Arabia, 21573
Al Abeer Polyclinic Recruiting
Jeddah, Saudi Arabia, 23531
Al Rahman Polyclinic Recruiting
Makkah, Saudi Arabia, 24232
Shifa Hospital Recruiting
Makkah, Saudi Arabia, 24232
Al-Noor Specialist Hospital Recruiting
Makkah, Saudi Arabia, 24241
Al Zafer Hospital Recruiting
Najran, Saudi Arabia, 66261
Al Hada Armed Forces Hospital Recruiting
Taif, Saudi Arabia, 21944
Al Amal Medical Group Recruiting
Yanbu, Saudi Arabia, 46455
Alansari Specialist Hospital Recruiting
Yanbu, Saudi Arabia, 46455
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Ahmed Mansour, +201028866717 ahmed.mansour@boehringer-ingelheim.com

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03764631     History of Changes
Other Study ID Numbers: 1245-0149
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dehydration
Ketosis
Hypovolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Pathologic Processes
Acidosis
Acid-Base Imbalance
Empagliflozin
Dipeptidyl-Peptidase IV Inhibitors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors