Japanese P III vs Voglibose and Placebo

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654381
• Other study ID #: 1218.23
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: December 11, 2013
• Start date: April 2008

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BI 1356
5 mg/daily
• BI 1356
10 mg/daily
• voglibose placebo
three times daily
• BI 1356 placebo
once daily
• voglibose
0.6 mg/daily

Locations

Country	Name	City	State
Japan	1218.23.05 Boehringer Ingelheim Investigational Site	Asahi, Chiba
Japan	1218.23.06 Boehringer Ingelheim Investigational Site	Funabashi, Chiba
Japan	1218.23.21 Boehringer Ingelheim Investigational Site	Hitachinaka, Ibaraki
Japan	1218.23.44 Boehringer Ingelheim Investigational Site	Hitachiota, Ibaraki
Japan	1218.23.09 Boehringer Ingelheim Investigational Site	Imizu, Toyama
Japan	1218.23.45 Boehringer Ingelheim Investigational Site	Inashiki-gun, Ibaraki
Japan	1218.23.13 Boehringer Ingelheim Investigational Site	Izumisano, Osaka
Japan	1218.23.27 Boehringer Ingelheim Investigational Site	Kariya, Aichi
Japan	1218.23.47 Boehringer Ingelheim Investigational Site	Kitakatsushika-gun, Saitama
Japan	1218.23.39 Boehringer Ingelheim Investigational Site	Kitakyuushuu, Fukuoka
Japan	1218.23.02 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1218.23.03 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1218.23.10 Boehringer Ingelheim Investigational Site	Kyoto, Kyoto
Japan	1218.23.37 Boehringer Ingelheim Investigational Site	Marugame, Kagawa
Japan	1218.23.38 Boehringer Ingelheim Investigational Site	Marugame, Kagawa
Japan	1218.23.23 Boehringer Ingelheim Investigational Site	Matsumoto, Nagano
Japan	1218.23.07 Boehringer Ingelheim Investigational Site	Meguro-ku, Tokyo
Japan	1218.23.25 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.23.26 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.23.28 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.23.29 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.23.30 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.23.04 Boehringer Ingelheim Investigational Site	Naka, Ibaraki
Japan	1218.23.15 Boehringer Ingelheim Investigational Site	Nishi-ku, Hiroshima, Hiroshima
Japan	1218.23.34 Boehringer Ingelheim Investigational Site	Nishi-ku, Sakai, Osaka
Japan	1218.23.22 Boehringer Ingelheim Investigational Site	Nishishinjyuku, Shinjyuku-ku, Tokyo
Japan	1218.23.16 Boehringer Ingelheim Investigational Site	Oita, Oita
Japan	1218.23.40 Boehringer Ingelheim Investigational Site	Oita, Oita
Japan	1218.23.36 Boehringer Ingelheim Investigational Site	Okayama, Okayama
Japan	1218.23.11 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1218.23.12 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1218.23.32 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1218.23.33 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1218.23.35 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1218.23.17 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.18 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.19 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.41 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.42 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.43 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.23.01 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1218.23.20 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1218.23.46 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1218.23.08 Boehringer Ingelheim Investigational Site	Shinjyuku-ku,Tokyo
Japan	1218.23.14 Boehringer Ingelheim Investigational Site	Suita, Osaka
Japan	1218.23.31 Boehringer Ingelheim Investigational Site	Takatsuki, Osaka
Japan	1218.23.48 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Primary	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	26 weeks	No
Primary	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	52 weeks	Yes
Secondary	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	12 weeks	No
Secondary	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	26 weeks	No
Secondary	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	52 weeks	No
Secondary	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	12 weeks	No
Secondary	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	26 weeks	No
Secondary	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	52 weeks	No

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