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Japanese P III vs Voglibose and Placebo

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
BI 1356
BI 1356
voglibose placebo
BI 1356 placebo
voglibose
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
  2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
  3. Age: >= 20 and <= 80
  4. Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
  2. Impaired hepatic function
  3. History of severe allergy/hypersensitivity
  4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
  5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Sites / Locations

  • 1218.23.05 Boehringer Ingelheim Investigational Site
  • 1218.23.06 Boehringer Ingelheim Investigational Site
  • 1218.23.21 Boehringer Ingelheim Investigational Site
  • 1218.23.44 Boehringer Ingelheim Investigational Site
  • 1218.23.09 Boehringer Ingelheim Investigational Site
  • 1218.23.45 Boehringer Ingelheim Investigational Site
  • 1218.23.13 Boehringer Ingelheim Investigational Site
  • 1218.23.27 Boehringer Ingelheim Investigational Site
  • 1218.23.47 Boehringer Ingelheim Investigational Site
  • 1218.23.39 Boehringer Ingelheim Investigational Site
  • 1218.23.02 Boehringer Ingelheim Investigational Site
  • 1218.23.03 Boehringer Ingelheim Investigational Site
  • 1218.23.10 Boehringer Ingelheim Investigational Site
  • 1218.23.37 Boehringer Ingelheim Investigational Site
  • 1218.23.38 Boehringer Ingelheim Investigational Site
  • 1218.23.23 Boehringer Ingelheim Investigational Site
  • 1218.23.07 Boehringer Ingelheim Investigational Site
  • 1218.23.25 Boehringer Ingelheim Investigational Site
  • 1218.23.26 Boehringer Ingelheim Investigational Site
  • 1218.23.28 Boehringer Ingelheim Investigational Site
  • 1218.23.29 Boehringer Ingelheim Investigational Site
  • 1218.23.30 Boehringer Ingelheim Investigational Site
  • 1218.23.04 Boehringer Ingelheim Investigational Site
  • 1218.23.15 Boehringer Ingelheim Investigational Site
  • 1218.23.34 Boehringer Ingelheim Investigational Site
  • 1218.23.22 Boehringer Ingelheim Investigational Site
  • 1218.23.16 Boehringer Ingelheim Investigational Site
  • 1218.23.40 Boehringer Ingelheim Investigational Site
  • 1218.23.36 Boehringer Ingelheim Investigational Site
  • 1218.23.11 Boehringer Ingelheim Investigational Site
  • 1218.23.12 Boehringer Ingelheim Investigational Site
  • 1218.23.32 Boehringer Ingelheim Investigational Site
  • 1218.23.33 Boehringer Ingelheim Investigational Site
  • 1218.23.35 Boehringer Ingelheim Investigational Site
  • 1218.23.17 Boehringer Ingelheim Investigational Site
  • 1218.23.18 Boehringer Ingelheim Investigational Site
  • 1218.23.19 Boehringer Ingelheim Investigational Site
  • 1218.23.41 Boehringer Ingelheim Investigational Site
  • 1218.23.42 Boehringer Ingelheim Investigational Site
  • 1218.23.43 Boehringer Ingelheim Investigational Site
  • 1218.23.01 Boehringer Ingelheim Investigational Site
  • 1218.23.20 Boehringer Ingelheim Investigational Site
  • 1218.23.46 Boehringer Ingelheim Investigational Site
  • 1218.23.08 Boehringer Ingelheim Investigational Site
  • 1218.23.14 Boehringer Ingelheim Investigational Site
  • 1218.23.31 Boehringer Ingelheim Investigational Site
  • 1218.23.48 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

voglibose 0.2 mg three times a day (TID)

BI 1356 low dose

BI 1356 high dose

placebo

Arm Description

patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356

patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose

patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose

patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in HbA1c at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks

Secondary Outcome Measures

Relative Efficacy Response of HbA1c at Week 12
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Relative Efficacy Response of HbA1c at Week 26
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Relative Efficacy Response of HbA1c at Week 52
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Full Information

First Posted
April 3, 2008
Last Updated
December 11, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00654381
Brief Title
Japanese P III vs Voglibose and Placebo
Official Title
A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
voglibose 0.2 mg three times a day (TID)
Arm Type
Active Comparator
Arm Description
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
Arm Title
BI 1356 low dose
Arm Type
Experimental
Arm Description
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
Arm Title
BI 1356 high dose
Arm Type
Experimental
Arm Description
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Intervention Type
Drug
Intervention Name(s)
BI 1356
Intervention Description
5 mg/daily
Intervention Type
Drug
Intervention Name(s)
BI 1356
Intervention Description
10 mg/daily
Intervention Type
Drug
Intervention Name(s)
voglibose placebo
Intervention Description
three times daily
Intervention Type
Drug
Intervention Name(s)
BI 1356 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
voglibose
Intervention Description
0.6 mg/daily
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 12
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame
12 weeks
Title
Change From Baseline in HbA1c at Week 26
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame
26 weeks
Title
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Description
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Relative Efficacy Response of HbA1c at Week 12
Description
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Time Frame
12 weeks
Title
Relative Efficacy Response of HbA1c at Week 26
Description
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Time Frame
26 weeks
Title
Relative Efficacy Response of HbA1c at Week 52
Description
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
Time Frame
52 weeks
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame
12 weeks
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame
26 weeks
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Description
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase) Age: >= 20 and <= 80 Body Mass Index (BMI) <= 40 kg/m2 Exclusion criteria: Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1 Impaired hepatic function History of severe allergy/hypersensitivity Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1 Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1218.23.05 Boehringer Ingelheim Investigational Site
City
Asahi, Chiba
Country
Japan
Facility Name
1218.23.06 Boehringer Ingelheim Investigational Site
City
Funabashi, Chiba
Country
Japan
Facility Name
1218.23.21 Boehringer Ingelheim Investigational Site
City
Hitachinaka, Ibaraki
Country
Japan
Facility Name
1218.23.44 Boehringer Ingelheim Investigational Site
City
Hitachiota, Ibaraki
Country
Japan
Facility Name
1218.23.09 Boehringer Ingelheim Investigational Site
City
Imizu, Toyama
Country
Japan
Facility Name
1218.23.45 Boehringer Ingelheim Investigational Site
City
Inashiki-gun, Ibaraki
Country
Japan
Facility Name
1218.23.13 Boehringer Ingelheim Investigational Site
City
Izumisano, Osaka
Country
Japan
Facility Name
1218.23.27 Boehringer Ingelheim Investigational Site
City
Kariya, Aichi
Country
Japan
Facility Name
1218.23.47 Boehringer Ingelheim Investigational Site
City
Kitakatsushika-gun, Saitama
Country
Japan
Facility Name
1218.23.39 Boehringer Ingelheim Investigational Site
City
Kitakyuushuu, Fukuoka
Country
Japan
Facility Name
1218.23.02 Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
Country
Japan
Facility Name
1218.23.03 Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
Country
Japan
Facility Name
1218.23.10 Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
Country
Japan
Facility Name
1218.23.37 Boehringer Ingelheim Investigational Site
City
Marugame, Kagawa
Country
Japan
Facility Name
1218.23.38 Boehringer Ingelheim Investigational Site
City
Marugame, Kagawa
Country
Japan
Facility Name
1218.23.23 Boehringer Ingelheim Investigational Site
City
Matsumoto, Nagano
Country
Japan
Facility Name
1218.23.07 Boehringer Ingelheim Investigational Site
City
Meguro-ku, Tokyo
Country
Japan
Facility Name
1218.23.25 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.23.26 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.23.28 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.23.29 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.23.30 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1218.23.04 Boehringer Ingelheim Investigational Site
City
Naka, Ibaraki
Country
Japan
Facility Name
1218.23.15 Boehringer Ingelheim Investigational Site
City
Nishi-ku, Hiroshima, Hiroshima
Country
Japan
Facility Name
1218.23.34 Boehringer Ingelheim Investigational Site
City
Nishi-ku, Sakai, Osaka
Country
Japan
Facility Name
1218.23.22 Boehringer Ingelheim Investigational Site
City
Nishishinjyuku, Shinjyuku-ku, Tokyo
Country
Japan
Facility Name
1218.23.16 Boehringer Ingelheim Investigational Site
City
Oita, Oita
Country
Japan
Facility Name
1218.23.40 Boehringer Ingelheim Investigational Site
City
Oita, Oita
Country
Japan
Facility Name
1218.23.36 Boehringer Ingelheim Investigational Site
City
Okayama, Okayama
Country
Japan
Facility Name
1218.23.11 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.23.12 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.23.32 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.23.33 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.23.35 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1218.23.17 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.18 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.19 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.41 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.42 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.43 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1218.23.01 Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
Country
Japan
Facility Name
1218.23.20 Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
Country
Japan
Facility Name
1218.23.46 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
Country
Japan
Facility Name
1218.23.08 Boehringer Ingelheim Investigational Site
City
Shinjyuku-ku,Tokyo
Country
Japan
Facility Name
1218.23.14 Boehringer Ingelheim Investigational Site
City
Suita, Osaka
Country
Japan
Facility Name
1218.23.31 Boehringer Ingelheim Investigational Site
City
Takatsuki, Osaka
Country
Japan
Facility Name
1218.23.48 Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22234149
Citation
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Results Reference
derived
PubMed Identifier
19732457
Citation
Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.23_U10-1466.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.23_Literature.pdf
Description
Related Info

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Japanese P III vs Voglibose and Placebo

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