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

NCT01947855 | Completed Phase 3 Results

• 1 other identifier: 1245.35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment

  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.

  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

Study Arms (3)

Empagliflozin low dose

EXPERIMENTAL

Empagliflozin low dose tablet once daily

Drug: Empagliflozin; Drug: Placebo

Empagliflozin high dose

EXPERIMENTAL

Empagliflozin high dose tablet once daily

Drug: Placebo; Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily

Drug: Placebo

Interventions

Placebo DRUG

Placebo tablet matching Empagliflozin low dose

Empagliflozin high dose

Empagliflozin DRUG

Empagliflozin low dose

Empagliflozin low dose

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

1245.35.002 Boehringer Ingelheim Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

1245.35.001 Boehringer Ingelheim Investigational Site

Suita-shi, Osaka, Japan

Location

Related Publications (3)

• Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

  PMID: 35472672 DERIVED

• Nishimura R, Tanaka Y, Koiwai K, Ishida K, Salsali A, Kaspers S, Kohler S, Lund SS. Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Adv Ther. 2019 Oct;36(10):2769-2782. doi: 10.1007/s12325-019-01045-x. Epub 2019 Aug 23.

  PMID: 31444706 DERIVED

• Nishimura R, Tanaka Y, Koiwai K, Inoue K, Hach T, Salsali A, Lund SS, Broedl UC. Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study. Cardiovasc Diabetol. 2015 Jan 30;14:11. doi: 10.1186/s12933-014-0169-9.

  PMID: 25633683 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 24, 2014
• Results First Posted: December 24, 2014

Record last verified: 2014-12

Locations

JP (2)