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OpenTrials
Completed

NCT Number: NCT03473262

Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes

This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c >7.5% and <12.0%

Exclusion criteria

  • Type 1 diabetes
  • Gestional diabetes
  • Diabetes due to secondary causes
  • Receiving anticancer treatment
  • Receiving glucocorticoids or immune-suppressants
  • Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
  • Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Treatment and study plan

Primary outcomes

  1. Changes in HbA1c From Baseline to Week 24

    Time frame: Baseline, Week 24

  2. Changes in Fasting Plasma Glucose From Baseline to Week 24

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24

    Time frame: Baseline, Week 24

  2. Changes in HbA1c From Baseline to Week 12

    Time frame: Baseline, Week 12

  3. Changes in Fasting Plasma Glucose From Baseline to Week 12

    Time frame: Baseline, Week 24

  4. Changes in Weight Between Baseline and Week 24

    Time frame: Baseline, Week 24

  5. Changes in Body Mass Index Between Baseline and Week 24

    Time frame: Baseline, Week 24

  6. Changes in Total Cholesterol Between Baseline and Week 24

    Time frame: Baseline, Week 24

  7. Changes in HDL Cholesterol Between Baseline and Week 24

    Time frame: Baseline, Week 24

  8. Changes in LDL Cholesterol Between Baseline and Week 24

    Time frame: Baseline, Week 24

  9. Changes in Triglycerides Between Baseline and Week 24

    Time frame: Baseline, Week 24

  10. Changes in Systolic Blood Pressure Between Baseline and Week 24

    Time frame: Baseline, Week 24

  11. Changes in Dystolic Blood Pressure Between Baseline and Week 24

    Time frame: Baseline, Week 24

  12. Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24

    Time frame: Baseline, Week 24

    All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.

  13. Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24

    Time frame: Baseline, Week 24

Sponsors and collaborators

Lead sponsor

Chungbuk National University Hospital

Other

Registry information

Official study title

Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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