Phase 3 Completed N=2,121 Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00736099 ↗

Enrolled (actual)

2,121

Serious AEs

9.9%

Results posted

Mar 2012

Primary outcomePrimary: Frequency of Patients With Adverse Events (AEs) — 1253; 465; 57; 23 Participants

Summary

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)

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Patients With Adverse Events (AEs)	1253; 465; 57; 23; 57; 16	—
PRIMARY Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events	209; 86	—
PRIMARY Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	20; 10; 7; 3; 21; 5	—
PRIMARY Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events	82; 37	—
PRIMARY Number of Patients With Abnormalities in Vital Signs	0; 0	—
PRIMARY Number of Patients With Abnormalities in Haematology: Eosinophils	91; 33	—
PRIMARY Number of Patients With Abnormalities in Haematology: Haemoglobin	63; 31	—
PRIMARY Number of Patients With Abnormalities in Haematology: Haematocrit	48; 22	—
PRIMARY Number of Patients With Abnormalities in Haematology: Red Blood Cell Count	31; 13	—
PRIMARY Number of Patients With Abnormalities in Haematology: White Blood Cell Count	30; 10; 1; 1	—
PRIMARY Number of Patients With Abnormalities in Haematology: Platelets	5; 0; 0; 0	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Potassium	3; 0; 135; 50	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid	124; 48	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides	329; 101	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Amylase	92; 35	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)	54; 14	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Creatinine	52; 18	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase	49; 6	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Phosphate	11; 8; 38; 11	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Calcium	36; 12; 4; 0	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Sodium	16; 3; 13; 8	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)	22; 5	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)	19; 3	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Glucose	7; 1	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin	6; 3	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)	7; 0	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Albumin	3; 1	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)	1; 0	—
PRIMARY Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol	1; 1	—
SECONDARY Change in HbA1c From Baseline to Week 6	-0.02; -0.46	—
SECONDARY Change in HbA1c From Baseline to Week 18	0.03; -0.63	—
SECONDARY Change in HbA1c From Baseline to Week 30	0.06; -0.60	—
SECONDARY Change in HbA1c From Baseline to Week 42	0.13; -0.53	—
SECONDARY Change in HbA1c From Baseline to Week 54	0.19; -0.45	—
SECONDARY Change in HbA1c From Baseline to Week 66	0.14; -0.44	—
SECONDARY Change in HbA1c From Baseline to Week 78	0.12; -0.49	—
SECONDARY Number of Patients With HbA1c<7.0% Over Time	382; 172	—
SECONDARY Number of Patients With HbA1c<6.5% Over Time	139; 74	—
SECONDARY Number of Patients With Lowered HbA1c by at Least 0.5% Over Time	155; 175	—
SECONDARY Change in FPG From Baseline to Week 6	1.21; -15.17	—
SECONDARY Change in FPG From Baseline to Week 18	2.13; -13.92	—
SECONDARY Change in FPG From Baseline to Week 30	1.52; -16.17	—
SECONDARY Change in FPG From Baseline to Week 42	2.97; -11.87	—
SECONDARY Change in FPG From Baseline to Week 54	3.44; -12.62	—
SECONDARY Change in FPG From Baseline to Week 66	0.88; -12.87	—
SECONDARY Change in FPG From Baseline to Week 78	1.90; -13.64	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00736099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.