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Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01947855
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: Empagliflozin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Empagliflozin low dose
Empagliflozin low dose tablet once daily
Drug: Empagliflozin
Empagliflozin low dose
Drug: Placebo
Placebo tablet matching Empagliflozin high dose
Experimental: Empagliflozin high dose
Empagliflozin high dose tablet once daily
Drug: Placebo
Placebo tablet matching Empagliflozin low dose
Drug: Empagliflozin
Empagliflozin high dose tablet once daily
Placebo Comparator: Placebo
Placebo tablet once daily
Drug: Placebo
Placebo tablet matching Empagliflozin high dose
Drug: Placebo
Placebo tablet matching Empagliflozin low dose



Primary Outcome Measures :
  1. Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment [ Time Frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 ]
    The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of type 2 diabetes mellitus prior to informed consent
  • Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:

    • drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
    • pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
  • Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

    • for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0%
    • for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5%

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
  • Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
  • Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
  • Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

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): NCT01947855


Locations
Japan
1245.35.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo, Japan
1245.35.001 Boehringer Ingelheim Investigational Site
Suita-shi, Osaka, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01947855     History of Changes
Other Study ID Numbers: 1245.35
First Posted: September 23, 2013    Key Record Dates
Results First Posted: December 24, 2014
Last Update Posted: December 24, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs