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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014