Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

NCT00601250 | Completed Phase 3 Results

• 2 other identifiers: 1218.172007-002457-24
• Study Type: interventional
• Target: 701
• Locations: 10 countries
• Sites: 82

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline at Week 24

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  Baseline and week 24

Secondary Outcomes (14)

• HbA1c Change From Baseline at Week 6

  Baseline and week 6

• HbA1c Change From Baseline at Week 12

  Baseline and week 12

• HbA1c Change From Baseline at Week 18

  Baseline and week 18

• FPG Change From Baseline at Week 24

  Baseline and week 24

• FPG Change From Baseline at Week 6

  Baseline and week 6

Study Arms (2)

Linagliptin

EXPERIMENTAL

Patients receive linagliptin 5 mg tablets once daily

Drug: linagliptin

Placebo

PLACEBO COMPARATOR

Patients receive placebo tablets matching linagliptin 5 mg tablets once daily

Drug: linagliptin

Interventions

linagliptin DRUG

Patients receive linagliptin 5 mg tablets once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 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 mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
• Diagnosis of type 2 diabetes prior to informed consent
• Glycosylated haemoglobin A1 (HbA1c)at screening:
• For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
• Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
• Age 18 -80 years
• BMI (Body Mass Index) less than 40 kg/m2
• Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

You may not qualify if:

• Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
• Impaired hepatic function
• Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
• Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
• Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
• Treatment with insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
• Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
• Participation in another trial with an investigational drug within 2 months prior to informed consent
• Pre-menopausal women who:
• 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.
• Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
• Renal failure or renal impairment
• Unstable or acute congestive heart failure

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (82)

1218.17.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.17.10014 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1218.17.10001 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

1218.17.10021 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Location

1218.17.10010 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1218.17.10011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.17.10008 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1218.17.10017 Boehringer Ingelheim Investigational Site

Gurnee, Illinois, United States

Location

1218.17.10006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1218.17.10012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1218.17.10013 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Location

1218.17.10015 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1218.17.10016 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

1218.17.10002 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.17.10004 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Location

1218.17.10005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.17.10018 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.17.10007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.17.10009 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1218.17.42001 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.17.42004 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.17.42007 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.17.42009 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.17.42006 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

Location

1218.17.42008 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1218.17.42003 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1218.17.35806 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1218.17.35804 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

1218.17.35801 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1218.17.35803 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1218.17.35805 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

1218.17.35802 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1218.17.30004 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.17.30013 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.17.30011 Boehringer Ingelheim Investigational Site

Piraeus, Greece

Location

1218.17.91009 Boehringer Ingelheim Investigational Site

Andhra Pradesh, India

Location

1218.17.91002 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.17.91005 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.17.91012 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.17.91014 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.17.91010 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1218.17.91006 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.17.91007 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

1218.17.91008 Boehringer Ingelheim Investigational Site

Mangalore, India

Location

1218.17.91004 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.17.91011 Boehringer Ingelheim Investigational Site

Nagpur, India

Location

1218.17.91003 Boehringer Ingelheim Investigational Site

Nashik, India

Location

1218.17.91001 Boehringer Ingelheim Investigational Site

Trivandrum, India

Location

1218.17.91013 Boehringer Ingelheim Investigational Site

Uttar Pradesh, India

Location

1218.17.97274 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1218.17.97273 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1218.17.97275 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1218.17.97271 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.17.97272 Boehringer Ingelheim Investigational Site

Nahariya, Israel

Location

1218.17.97276 Boehringer Ingelheim Investigational Site

Safed, Israel

Location

1218.17.97278 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1218.17.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, Ags., Mexico

Location

1218.17.52009 Boehringer Ingelheim Investigational Site

cOL OBREGON,León, Guanajuato, Mexico

Location

1218.17.52003 Boehringer Ingelheim Investigational Site

Col. Lomas de San Francisco, Monterrey, Mexico

Location

1218.17.52001 Boehringer Ingelheim Investigational Site

Col. Mitras Centro, Monterrey, N.L., Mexico

Location

1218.17.52010 Boehringer Ingelheim Investigational Site

Col.Americana, Guadalajara, Jalisco, Mexico

Location

1218.17.52008 Boehringer Ingelheim Investigational Site

Colonia Tlalpan, Mexico, Mexico

Location

1218.17.52006 Boehringer Ingelheim Investigational Site

Faccionamiento Lomas de Campestre,AGUASCAL, Mexico

Location

1218.17.52005 Boehringer Ingelheim Investigational Site

Lomas de Reforma, Mexico

Location

1218.17.52002 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.17.52004 Boehringer Ingelheim Investigational Site

Tlalpan-México D,F, Mexico

Location

1218.17.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1218.17.64003 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

1218.17.64002 Boehringer Ingelheim Investigational Site

Otahuhu, New Zealand

Location

1218.17.64001 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1218.17.64005 Boehringer Ingelheim Investigational Site

Wellington, New Zealand

Location

1218.17.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.17.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.17.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.17.70005 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1218.17.70006 Boehringer Ingelheim Investigational Site

Perm, Russia

Location

1218.17.70004 Boehringer Ingelheim Investigational Site

Tomsk, Russia

Location

1218.17.46013 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1218.17.46001 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.17.46012 Boehringer Ingelheim Investigational Site

Uddevalla, Sweden

Location

1218.17.46004 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.17.46015 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

Related Publications (1)

• Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.

  PMID: 27484756 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

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: January 15, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: January 28, 2014
• Results First Posted: June 7, 2011

Record last verified: 2013-12

Locations

RU (6); NZ (5); ME (10); US (19); FI (6); IL (7); GR (3); IN (14); SE (5); CZ (7)