Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00885118
NCT00885118
Completed
Phase 2

A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim5 sites in 1 country100 target enrollmentApril 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetes Mellitus, Type 2
InterventionsPlacebo (low dose)BI 10773Placebo (middle dose)Placebo (high dose)Placebo
DrugsPlacebo (middle dose)PlaceboBI 10773Placebo (high dose)Placebo (low dose)

Overview

Phase
Phase 2
Intervention
Placebo (low dose)
Conditions
Diabetes Mellitus, Type 2
Sponsor
Boehringer Ingelheim
Enrollment
100
Locations
5
Primary Endpoint
Change From Baseline in Urine Glucose Excretion
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
October 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

BI 10773 low dose quaque die (QD)

patient to receive a BI 10773 low dose tablet and a placebo tablet once daily

Intervention: Placebo (low dose)

BI 10773 mid-high dose QD

patient to receive two tablets of BI 10773 middle dose once daily

Intervention: BI 10773

BI 10773 low dose quaque die (QD)

patient to receive a BI 10773 low dose tablet and a placebo tablet once daily

Intervention: BI 10773

BI 10773 mid-low dose QD

patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily

Intervention: Placebo (middle dose)

BI 10773 mid-low dose QD

patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily

Intervention: BI 10773

BI 10773 high dose QD

patient to receive a BI 10773 high dose tablet and a placebo tablet once daily

Intervention: BI 10773

BI 10773 high dose QD

patient to receive a BI 10773 high dose tablet and a placebo tablet once daily

Intervention: Placebo (high dose)

Placebo

patient to receive two tablets of placebo once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Urine Glucose Excretion

Time Frame: baseline and 28 days

Change from baseline in Urine glucose excretion to 28 days

Change From Baseline in 8-point Glucose

Time Frame: baseline and 27 days

Change from baseline in 8-point glucose to 27 days

Change From Baseline in Fasting Plasma Glucose

Time Frame: baseline and 28 days

Change from baseline in Fasting plasma glucose to 28 days

Secondary Outcomes

  • Change From Baseline in HbA1c(baseline and 28 days)
  • CL/F(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • Vz/F(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • Change From Baseline in Fructosamine(baseline and 28 days)
  • Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
  • Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
  • fe0-24(0-5, 5-12, 12-24 hour after first drug administration)
  • Cmax,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
  • CLR,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration)
  • Change From Baseline in 1,5-anhydroglucitol(baseline and 28 days)
  • Change From Baseline in Fasting Insulin(baseline and 28 days)
  • Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)(baseline and 28 days)
  • AUCτ,1(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • AUC0-tz(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • AUC0-∞(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • Cmax(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • Ae0-24(0-5, 5-12, 12-24 hour after first drug administration)
  • CLR,0-24(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration)
  • RA,Cmax(Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
  • t1/2(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration)
  • AUCτ,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
  • t1/2,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
  • CL/F,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
  • Vz/F,ss(Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration)
  • RA,AUC(Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration)
  • Ae0-24,ss(0-5, 5-12, 12-24 hour after last drug administration)
  • fe0-24,ss(0-5, 5-12, 12-24 hour after last drug administration)

Study Sites (5)

Loading locations...

Similar Trials

Withdrawn
Phase 2
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery PatientsHypotensionCardiopulmonary Bypass
NCT00482287Meditor Pharmaceuticals Ltd.
Terminated
Phase 2
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisDiffuse Cutaneous Systemic Sclerosis
NCT02465437Corbus Pharmaceuticals Inc.42
Completed
Phase 2
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic FibrosisCystic Fibrosis
NCT02465450Corbus Pharmaceuticals Inc.85
Recruiting
Phase 1
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)Myotonic Dystrophy Type 1 (DM1)
NCT06185764Vertex Pharmaceuticals Incorporated44
Completed
Phase 2
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a BunionectomyAcute Pain
NCT06619847Vertex Pharmaceuticals Incorporated367