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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01947855
First received: September 18, 2013
Last updated: January 14, 2014
Last verified: January 2014

September 18, 2013
January 14, 2014
September 2013
December 2013   (final data collection date for primary outcome measure)
change in area under the concentration-time curve (AUC1-4h) for postprandial plasma glucose from baseline after 28 days of treatment [ Time Frame: day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01947855 on ClinicalTrials.gov Archive Site
Not Provided
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Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo tablet matching Empagliflozin low dose
  • Drug: Empagliflozin
    Empagliflozin low dose
  • Drug: Placebo
    Placebo tablet matching Empagliflozin high dose
  • Drug: Empagliflozin
    Empagliflozin high dose tablet once daily
  • Experimental: Empagliflozin low dose
    Empagliflozin low dose tablet once daily
    Interventions:
    • Drug: Empagliflozin
    • Drug: Placebo
  • Experimental: Empagliflozin high dose
    Empagliflozin high dose tablet once daily
    Interventions:
    • Drug: Placebo
    • Drug: Empagliflozin
  • Placebo Comparator: Placebo
    Placebo tablet once daily
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01947855
1245.35
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP