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Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

NCT ID: NCT00328172

Last Updated: 2014-03-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Placebo tablets matching BI 1356

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 1356

BI 1356 0.5 mg

BI 1356 dose 1 once daily

Group Type EXPERIMENTAL

BI 1356 dose 1 once daily

Intervention Type DRUG

BI 1356 dose 1 once daily

BI 1356 2.5 mg

BI 1356 dose 2 once daily

Group Type EXPERIMENTAL

BI 1356 dose 2 once daily

Intervention Type DRUG

BI 1356 dose 2 once daily

BI 1356 5.0 mg

BI 1356 dose 3 once daily

Group Type EXPERIMENTAL

BI 1356 dose 3 once daily

Intervention Type DRUG

BI 1356 dose 3 once daily

Metformin

Metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin

Interventions

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Placebo

Placebo matching BI 1356

Intervention Type DRUG

BI 1356 dose 3 once daily

BI 1356 dose 3 once daily

Intervention Type DRUG

BI 1356 dose 2 once daily

BI 1356 dose 2 once daily

Intervention Type DRUG

BI 1356 dose 1 once daily

BI 1356 dose 1 once daily

Intervention Type DRUG

Metformin

Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
2. Diagnosis of Type 2 diabetes with duration of at least 3 months
3. Glycosylated haemoglobin A1 (HbA1c) of:

7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
5. Age \>=21 and \<=75 years.
6. BMI (Body Mass Index) \>=25.0 and \<=40 kg/m2.
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
8. Treatment with insulin within 3 months prior to screening
9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
11. Fasting plasma glucose \>240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
12. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who:

1. are not surgically sterile,
2. or are nursing or pregnant;
3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
13. Intolerance of metformin
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.5.10020 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1218.5.10001 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

1218.5.10007 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Site Status

1218.5.10041 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1218.5.10018 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Site Status

1218.5.10016 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1218.5.10003 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1218.5.10011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1218.5.10012 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1218.5.10017 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1218.5.10008 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

Site Status

1218.5.10024 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Site Status

1218.5.10039 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1218.5.10032 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

1218.5.10025 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Site Status

1218.5.10034 Boehringer Ingelheim Investigational Site

Butte, Montana, United States

Site Status

1218.5.10009 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

1218.5.10042 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Site Status

1218.5.10029 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Site Status

1218.5.10004 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Site Status

1218.5.10026 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1218.5.10035 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Site Status

1218.5.10023 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

1218.5.10030 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1218.5.10044 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

1218.5.10033 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1218.5.10038 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Site Status

1218.5.10006 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.5.10040 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1218.5.10036 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.5.10021 Boehringer Ingelheim Investigational Site

Tyler, Texas, United States

Site Status

1218.5.10027 Boehringer Ingelheim Investigational Site

Salem, Virginia, United States

Site Status

1218.5.10022 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Site Status

1218.5.10014 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Site Status

1218.5.61001 Boehringer Ingelheim Investigational Site

Miranda, New South Wales, Australia

Site Status

1218.5.61005 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Site Status

1218.5.61006 Boehringer Ingelheim Investigational Site

Dandenong, Victoria, Australia

Site Status

1218.5.61007 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

Site Status

1218.5.61004 Boehringer Ingelheim Investigational Site

Fremantle, Western Australia, Australia

Site Status

1218.5.61002 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Site Status

1218.5.11011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.5.11016 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.5.11003 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Site Status

1218.5.11004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.5.11013 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.5.11015 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1218.5.11005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1218.5.11014 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1218.5.11010 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1218.5.11009 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.5.11012 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

Site Status

1218.5.11002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.5.11006 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Site Status

1218.5.11017 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Site Status

1218.5.11018 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1218.5.42002 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

Site Status

1218.5.42003 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1218.5.42004 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1218.5.42005 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1218.5.42001 Boehringer Ingelheim Investigational Site

Sternberk, , Czechia

Site Status

1218.5.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.5.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.5.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.5.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.5.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.5.38005 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.5.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.5.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.5.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.5.38004 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.5.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

Countries

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United States Australia Canada Czechia Russia Ukraine

Other Identifiers

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1218.5

Identifier Type: -

Identifier Source: org_study_id

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