Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: linagliptine 5 mg; Drug: linagliptine 5 mg and pioglitazone 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736099

1218.40

2008-000750-13 (EudraCT Number)

Details and patient eligibility

About

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Enrollment: 2,122 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated written informed consent in accordance with the GCP and local legislation.
2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Exclusion criteria

1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.

2. Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) 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. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.

3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.

4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation.

5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,122 participants in 2 patient groups

linagliptin 5 mg

Experimental group

Description:

open label

Treatment:

Drug: linagliptine 5 mg

linagliptin 5 mg and pioglitazone 30 mg

Experimental group

Description:

open label

Treatment:

Drug: linagliptine 5 mg and pioglitazone 30 mg