Phase 3
Completed N=389
Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
Source: ClinicalTrials.gov NCT00641043 ↗Enrolled (actual)
389
Serious AEs
2.8%
Results posted
Jun 2011
Primary outcomePrimary: HbA1c Change From Baseline to Week 24 — -0.56; -1.06 Percent — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline to Week 24 |
-0.56; -1.06 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 6 |
-0.03; -0.41 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 12 |
-0.35; -0.85 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 18 |
-0.55; -1.06 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 24 |
-18.4; -32.6 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 6 |
-17.0; -33.3 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 12 |
-20.5; -33.8 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 18 |
-19.3; -33.2 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24 |
30.5; 42.9 | 0.0051 sig |
| SECONDARY Percentage of Patients With HbA1c<7.0 at Week 24 |
30.5; 42.9 | — |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 24 |
14.1; 17.5 | 0.3547 |
| SECONDARY Percentage of Patients With HbA1c<6.5% at Week 24 |
14.1; 17.5 | — |
| SECONDARY Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24 |
50.8; 75.0 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Signed and dated written Informed Consent (IC) by date of Visit 1a in accordance with Good Clinical Practice (GCP) and local legislation
- Patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.
- Glycosylated haemoglobin A1 (HbA1c) 7.5-11% at Visit 2 (Start of Run-in).
- Male and female patients aged > or = 18 and 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
- Pre-menopausal women (last menstruation < or =1 year prior to signing IC) 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. No exception will be made.
- Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
- Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
- Diabetic ketoacidosis within 6 months prior to IC.
- Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
- Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.
Data sourced from ClinicalTrials.gov (NCT00641043). 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.