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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT00601250

Run by

Boehringer Ingelheim

People needed

701

Starts

2008-01-01

Last updated by the study team

2014-01-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• Acute or chronic metabolic acidosis (present in patient history)
• Hereditary galactose intolerance

Where it is running

• 1218.17.10014 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 1218.17.10001 Boehringer Ingelheim Investigational Site — Walnut Creek, California, United States
• 1218.17.10021 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
• 1218.17.10010 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 1218.17.10011 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.17.10008 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• 1218.17.10017 Boehringer Ingelheim Investigational Site — Gurnee, Illinois, United States
• 1218.17.10006 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1218.17.10012 Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
• 1218.17.10013 Boehringer Ingelheim Investigational Site — Mentor, Ohio, United States
• 1218.17.10015 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1218.17.10016 Boehringer Ingelheim Investigational Site — Eugene, Oregon, United States
• 1218.17.10002 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1218.17.10004 Boehringer Ingelheim Investigational Site — Simpsonville, South Carolina, United States
• 1218.17.10005 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.17.10018 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1218.17.10007 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.17.10009 Boehringer Ingelheim Investigational Site — Federal Way, Washington, United States
• 1218.17.42001 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1218.17.42004 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1218.17.42007 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1218.17.42009 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1218.17.42006 Boehringer Ingelheim Investigational Site — Břeclav, Czechia
• 1218.17.42008 Boehringer Ingelheim Investigational Site — Hodonín, Czechia
• 1218.17.10003 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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