Phase 3
Completed N=566
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Source: ClinicalTrials.gov NCT00915772 ↗Enrolled (actual)
566
Serious AEs
5.8%
Results posted
Jul 2012
Primary outcomePrimary: Frequency of Patients With Adverse Events (AEs) — 124; 149; 132; 4 participant
Summary
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Patients With Adverse Events (AEs) |
124; 149; 132; 4; 7; 5 | — |
| PRIMARY Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) |
-0.3; -0.1; 0.3; 0.6; -0.2; 2.2 | — |
| PRIMARY Change From Baseline at Week 54 in Pulse Rate |
0.0; 0.6; 0.1 | — |
| PRIMARY Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology |
2; 2; 0; 7; 4; 2 | — |
| PRIMARY Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry |
2; 4; 6; 0; 1; 2 | — |
| PRIMARY Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Change in HbA1c From Baseline Over Time |
-1.19; -1.34; -1.74; -1.16; -1.31; -1.62 | — |
| SECONDARY Number of Patients With HbA1c <7.0% After 54 Weeks |
119; 168; 104; 51; 57; 67 | — |
| SECONDARY Number of Patients With HbA1c <6.5% Over Time |
148; 196; 130; 22; 29; 41 | — |
| SECONDARY Number of Patients With HbA1c of at Least <0.5% Over Time |
143; 176; 135; 27; 49; 36 | — |
| SECONDARY Change in FPG From Baseline Over Time |
-4.36; -12.22; -10.57; -4.18; -13.28; -13.46 | — |
| SECONDARY Number of Patients With Rescue Therapy |
128; 163; 147; 42; 62; 24 | — |
Eligibility Criteria
Inclusion criteria
- Signed and dated written informed consent, at the latest by the date of Visit 1
- Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)
Exclusion criteria
- Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46
- Pre-menopausal women (last menstruation equal or less than 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, sexual abstinence and vasectomised partner and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made.
- Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation
- Drug abuse that 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 study medication
Data sourced from ClinicalTrials.gov (NCT00915772). 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.