Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

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 Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Key facts

Study ID

NCT00996658

Run by

Boehringer Ingelheim

People needed

278

Starts

2009-10-01

Last updated by the study team

2014-03-26

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus prior to informed consent
• Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
• Glycosylated haemoglobin A1 >= 7.5% and <= 10%
• Age between 18 and less than 80
• - Body Mass index less or equal to 45

You may not qualify if…

• Uncontrolled hyperglycaemia during run in period
• Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
• Impaired hepatic function
• Gastric by pass surgery
• Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs
• Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
• Premenopausal 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 during the trial

Where it is running

• 1218.61.01014 Boehringer Ingelheim Investigational Site — Greenbrae, California, United States
• 1218.61.01015 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.61.01042 Boehringer Ingelheim Investigational Site — Paramount, California, United States
• 1218.61.01046 Boehringer Ingelheim Investigational Site — Poway, California, United States
• 1218.61.01044 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1218.61.01009 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1218.61.01049 Boehringer Ingelheim Investigational Site — Lawrenceville, Georgia, United States
• 1218.61.01008 Boehringer Ingelheim Investigational Site — Roswell, Georgia, United States
• 1218.61.01040 Boehringer Ingelheim Investigational Site — Meridian, Idaho, United States
• 1218.61.01016 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1218.61.01018 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1218.61.01048 Boehringer Ingelheim Investigational Site — Lafayette, Indiana, United States
• 1218.61.01001 Boehringer Ingelheim Investigational Site — Auburn, Maine, United States
• 1218.61.01043 Boehringer Ingelheim Investigational Site — Olive Branch, Mississippi, United States
• 1218.61.01052 Boehringer Ingelheim Investigational Site — Las Vegas, Nevada, United States
• 1218.61.01030 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1218.61.01007 Boehringer Ingelheim Investigational Site — Greensboro, North Carolina, United States
• 1218.61.01004 Boehringer Ingelheim Investigational Site — Jacksonville, North Carolina, United States
• 1218.61.01023 Boehringer Ingelheim Investigational Site — Wilmington, North Carolina, United States
• 1218.61.01027 Boehringer Ingelheim Investigational Site — Perrysburg, Ohio, United States
• 1218.61.01031 Boehringer Ingelheim Investigational Site — East Providence, Rhode Island, United States
• 1218.61.01017 Boehringer Ingelheim Investigational Site — Simpsonville, South Carolina, United States
• 1218.61.01005 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1218.61.01006 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1218.61.01028 Boehringer Ingelheim Investigational Site — Escondido, California, United States

Full record on ClinicalTrials.gov

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