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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: Empagliflozin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01947855     History of Changes
Other Study ID Numbers: 1245.35
Study First Received: September 18, 2013
Last Updated: January 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014