Skip to main content
OpenTrials
Completed

NCT Number: NCT00736099

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.40.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
  • 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.
  • Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
  • Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
  • 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.

Treatment and study plan

linagliptine 5 mg

Drug

safety and efficacy of linagliptine 5 mg open label

linagliptine 5 mg and pioglitazone 30 mg

Drug

efficacy and safety of the combination linagliptine and pioglitazone

Primary outcomes

  1. Frequency of Patients With Adverse Events (AEs)

    Time frame: 78 weeks

    This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

  2. Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

    Time frame: 78 weeks

  3. Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)

    Time frame: 78 weeks

    As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').

  4. Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events

    Time frame: 78 weeks

    Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)

  5. Number of Patients With Abnormalities in Vital Signs

    Time frame: 78 weeks

    Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)

  6. Number of Patients With Abnormalities in Haematology: Eosinophils

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.

  7. Number of Patients With Abnormalities in Haematology: Haemoglobin

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.

  8. Number of Patients With Abnormalities in Haematology: Haematocrit

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.

  9. Number of Patients With Abnormalities in Haematology: Red Blood Cell Count

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.

  10. Number of Patients With Abnormalities in Haematology: White Blood Cell Count

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).

  11. Number of Patients With Abnormalities in Haematology: Platelets

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).

  12. Number of Patients With Abnormalities in Clinical Chemistry: Potassium

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).

  13. Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.

  14. Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

  15. Number of Patients With Abnormalities in Clinical Chemistry: Amylase

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).

  16. Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

  17. Number of Patients With Abnormalities in Clinical Chemistry: Creatinine

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.

  18. Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

  19. Number of Patients With Abnormalities in Clinical Chemistry: Phosphate

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).

  20. Number of Patients With Abnormalities in Clinical Chemistry: Calcium

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).

  21. Number of Patients With Abnormalities in Clinical Chemistry: Sodium

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).

  22. Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

  23. Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

  24. Number of Patients With Abnormalities in Clinical Chemistry: Glucose

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.

  25. Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.

  26. Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.

  27. Number of Patients With Abnormalities in Clinical Chemistry: Albumin

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.

  28. Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

  29. Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol

    Time frame: 78 weeks

    For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Secondary outcomes

  1. Change in HbA1c From Baseline to Week 6

    Time frame: Baseline and week 6

  2. Change in HbA1c From Baseline to Week 18

    Time frame: Baseline and week 18

  3. Change in HbA1c From Baseline to Week 30

    Time frame: Baseline and week 30

  4. Change in HbA1c From Baseline to Week 42

    Time frame: Baseline and week 42

  5. Change in HbA1c From Baseline to Week 54

    Time frame: Baseline and week 54

  6. Change in HbA1c From Baseline to Week 66

    Time frame: Baseline and week 66

  7. Change in HbA1c From Baseline to Week 78

    Time frame: Baseline and week 78

  8. Number of Patients With HbA1c<7.0% Over Time

    Time frame: 78 weeks

  9. Number of Patients With HbA1c<6.5% Over Time

    Time frame: 78 weeks

  10. Number of Patients With Lowered HbA1c by at Least 0.5% Over Time

    Time frame: 78 weeks

  11. Change in FPG From Baseline to Week 6

    Time frame: Baseline and week 6

  12. Change in FPG From Baseline to Week 18

    Time frame: Baseline and week 18

  13. Change in FPG From Baseline to Week 30

    Time frame: Baseline and week 30

  14. Change in FPG From Baseline to Week 42

    Time frame: Baseline and week 42

  15. Change in FPG From Baseline to Week 54

    Time frame: Baseline and week 54

  16. Change in FPG From Baseline to Week 66

    Time frame: Baseline and week 66

  17. Change in FPG From Baseline to Week 78

    Time frame: Baseline and week 78

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 15, 2008
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.