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

NCT00328172 | Completed Phase 2 Results

• 1 other identifier: 1218.5
• Study Type: interventional
• Target: 302
• Locations: 6 countries
• Sites: 71

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12

  The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.

  Baseline, week 12

Secondary Outcomes (2)

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

  Baseline, week 12

• Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks

  Baseline, week 12

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo tablets matching BI 1356

Drug: Placebo

BI 1356 0.5 mg

EXPERIMENTAL

BI 1356 dose 1 once daily

Drug: BI 1356 dose 1 once daily

BI 1356 2.5 mg

EXPERIMENTAL

BI 1356 dose 2 once daily

Drug: BI 1356 dose 2 once daily

BI 1356 5.0 mg

EXPERIMENTAL

BI 1356 dose 3 once daily

Drug: BI 1356 dose 3 once daily

Metformin

ACTIVE COMPARATOR

Metformin

Drug: Metformin

Interventions

Placebo DRUG

Placebo matching BI 1356

Placebo

BI 1356 dose 3 once daily DRUG

BI 1356 dose 3 once daily

BI 1356 5.0 mg

BI 1356 dose 2 once daily DRUG

BI 1356 dose 2 once daily

BI 1356 2.5 mg

BI 1356 dose 1 once daily DRUG

BI 1356 dose 1 once daily

BI 1356 0.5 mg

Metformin DRUG

Metformin

Metformin

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of Type 2 diabetes with duration of at least 3 months
• Glycosylated haemoglobin A1 (HbA1c) of:
• % 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)
• HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
• Age \>=21 and \<=75 years.
• BMI (Body Mass Index) \>=25.0 and \<=40 kg/m2.
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
• Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
• Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
• 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
• Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
• History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
• Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• Treatment with insulin within 3 months prior to screening
• Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• 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)
• Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who:
• are not surgically sterile,
• or are nursing or pregnant;
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (71)

1218.5.10020 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.5.10001 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

1218.5.10007 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

1218.5.10041 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1218.5.10018 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1218.5.10016 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1218.5.10003 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.5.10011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.5.10012 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1218.5.10017 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1218.5.10008 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

Location

1218.5.10024 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1218.5.10039 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1218.5.10032 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Location

1218.5.10025 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Location

1218.5.10034 Boehringer Ingelheim Investigational Site

Butte, Montana, United States

Location

1218.5.10009 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1218.5.10042 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

1218.5.10029 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

1218.5.10004 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Location

1218.5.10026 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1218.5.10035 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Location

1218.5.10023 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1218.5.10030 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.5.10044 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

1218.5.10033 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.5.10038 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Location

1218.5.10006 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.5.10040 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.5.10036 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.5.10021 Boehringer Ingelheim Investigational Site

Tyler, Texas, United States

Location

1218.5.10027 Boehringer Ingelheim Investigational Site

Salem, Virginia, United States

Location

1218.5.10022 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1218.5.10014 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1218.5.61001 Boehringer Ingelheim Investigational Site

Miranda, New South Wales, Australia

Location

1218.5.61005 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1218.5.61006 Boehringer Ingelheim Investigational Site

Dandenong, Victoria, Australia

Location

1218.5.61007 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

Location

1218.5.61004 Boehringer Ingelheim Investigational Site

Fremantle, Western Australia, Australia

Location

1218.5.61002 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Location

1218.5.11011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.5.11016 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.5.11003 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Location

1218.5.11004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.5.11013 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.5.11015 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1218.5.11005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.5.11014 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

1218.5.11010 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1218.5.11009 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.5.11012 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

Location

1218.5.11002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.5.11006 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Location

1218.5.11017 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Location

1218.5.11018 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1218.5.42002 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1218.5.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1218.5.42004 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1218.5.42005 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1218.5.42001 Boehringer Ingelheim Investigational Site

Sternberk, Czechia

Location

1218.5.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.5.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.5.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.5.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.5.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.5.38005 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.5.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.5.38002 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.5.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.5.38004 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.5.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Last Updated: March 14, 2014
• Results First Posted: June 7, 2011

Record last verified: 2014-02

Locations

UA (6); AU (6); US (34); CA (15); CZ (5); RU (5)