Japanese P III vs Voglibose and Placebo

NCT00654381 | Completed Phase 3 Results

• 1 other identifier: 1218.23
• Study Type: interventional
• Target: 561
• Locations: 1 country
• Sites: 47

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (6)

• Relative Efficacy Response of HbA1c at Week 12

  12 weeks

• Relative Efficacy Response of HbA1c at Week 26

  26 weeks

• Relative Efficacy Response of HbA1c at Week 52

  52 weeks

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

  12 weeks

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

  26 weeks

Study Arms (4)

voglibose 0.2 mg three times a day (TID)

ACTIVE COMPARATOR

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

Drug: voglibose

BI 1356 low dose

EXPERIMENTAL

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

Drug: BI 1356

BI 1356 high dose

EXPERIMENTAL

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

Drug: BI 1356

placebo

PLACEBO COMPARATOR

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

Drug: voglibose placebo; Drug: BI 1356 placebo

Interventions

BI 1356 DRUG

5 mg/daily

BI 1356 low dose

voglibose placebo DRUG

three times daily

placebo

BI 1356 placebo DRUG

once daily

placebo

voglibose DRUG

0.6 mg/daily

voglibose 0.2 mg three times a day (TID)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (47)

1218.23.05 Boehringer Ingelheim Investigational Site

Asahi, Chiba, Japan

Location

1218.23.06 Boehringer Ingelheim Investigational Site

Funabashi, Chiba, Japan

Location

1218.23.21 Boehringer Ingelheim Investigational Site

Hitachinaka, Ibaraki, Japan

Location

1218.23.44 Boehringer Ingelheim Investigational Site

Hitachiota, Ibaraki, Japan

Location

1218.23.09 Boehringer Ingelheim Investigational Site

Imizu, Toyama, Japan

Location

1218.23.45 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, Japan

Location

1218.23.13 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, Japan

Location

1218.23.27 Boehringer Ingelheim Investigational Site

Kariya, Aichi, Japan

Location

1218.23.47 Boehringer Ingelheim Investigational Site

Kitakatsushika-gun, Saitama, Japan

Location

1218.23.39 Boehringer Ingelheim Investigational Site

Kitakyuushuu, Fukuoka, Japan

Location

1218.23.02 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1218.23.03 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1218.23.10 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1218.23.37 Boehringer Ingelheim Investigational Site

Marugame, Kagawa, Japan

Location

1218.23.38 Boehringer Ingelheim Investigational Site

Marugame, Kagawa, Japan

Location

1218.23.23 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

Location

1218.23.07 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

1218.23.25 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.23.26 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.23.28 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.23.29 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.23.30 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.23.04 Boehringer Ingelheim Investigational Site

Naka, Ibaraki, Japan

Location

1218.23.15 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, Japan

Location

1218.23.34 Boehringer Ingelheim Investigational Site

Nishi-ku, Sakai, Osaka, Japan

Location

1218.23.22 Boehringer Ingelheim Investigational Site

Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan

Location

1218.23.16 Boehringer Ingelheim Investigational Site

Oita, Oita, Japan

Location

1218.23.40 Boehringer Ingelheim Investigational Site

Oita, Oita, Japan

Location

1218.23.36 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

1218.23.11 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.23.12 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.23.32 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.23.33 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.23.35 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.23.17 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.18 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.19 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.41 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.42 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.43 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.23.01 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1218.23.20 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1218.23.46 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1218.23.08 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

Location

1218.23.14 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1218.23.31 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, Japan

Location

1218.23.48 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

Related Publications (2)

• 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.

  PMID: 22234149 DERIVED

• 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.

  PMID: 19732457 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; voglibose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

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

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 8, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: January 27, 2014
• Results First Posted: August 2, 2011

Record last verified: 2013-12

Locations

JP (47)