Phase 3 Completed N=857 Randomized Double-blind Treatment

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00798161 ↗

Enrolled (actual)

857

Serious AEs

2.1%

Results posted

Aug 2011

Primary outcomePrimary: HbA1c Change From Baseline at Week 24 — 0.13; -0.64; -1.07; -0.45 Percent — p=<0.0001

Summary

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Outcome Measures

Outcome	Result	p-value
PRIMARY HbA1c Change From Baseline at Week 24	0.13; -0.64; -1.07; -0.45; -1.22; -1.59	<0.0001 sig
SECONDARY HbA1c Change From Baseline at Week 6	0.03; -0.45; -0.61; -0.36; -0.86; -1.00	<0.0001 sig
SECONDARY HbA1c Change From Baseline at Week 12	0.16; -0.61; -0.95; -0.42; -1.13; -1.37	<0.0001 sig
SECONDARY HbA1c Change From Baseline at Week 18	0.16; -0.66; -1.06; -0.45; -1.17; -1.54	<0.0001 sig
SECONDARY FPG Change From Baseline at Week 24	10.2; -15.8; -32.2; -8.6; -33.2; -49.4	0.0005 sig
SECONDARY FPG Change From Baseline at Week 2	5.3; -19.6; -21.8; -13.0; -34.5; -38.6	0.0003 sig
SECONDARY FPG Change From Baseline at Week 6	6.2; -20.8; -31.6; -10.8; -38.7; -48.3	<0.0001 sig
SECONDARY FPG Change From Baseline at Week 12	8.9; -21.8; -31.9; -8.4; -36.2; -49.9	0.0024 sig
SECONDARY FPG Change From Baseline at Week 18	7.3; -13.7; -30.3; -9.2; -34.6; -48.1	<0.0001 sig
SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24	10.8; 18.6; 30.7; 10.4; 30.1; 53.6	0.0062 sig
SECONDARY Percentage of Patients With HbA1c<7.0 at Week 24	10.8; 19.1; 31.2; 10.4; 30.7; 54.3	—
SECONDARY Percentage of Patients With HbA1c <6.5% at Week 24	3.1; 5.0; 12.3; 3.7; 13.1; 27.1	0.0102 sig
SECONDARY Percentage of Patients With HbA1c < 6.5% at Week 24	3.1; 5.0; 12.3; 3.7; 13.1; 27.1	—
SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% at Week 24	29.2; 46.1; 65.9; 42.2; 71.5; 81.4	<0.0001 sig
SECONDARY Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24	-35.4; -82.9; -87.2; -35.3; -86.0; -109.2	0.8893
SECONDARY HbA1c Change From Baseline at Week 24 for Open-label Patients	-3.19	—
SECONDARY FPG Change From Baseline at Week 24 for Open-label Patients	-73.58	—
SECONDARY Use of Rescue Therapy	29.2; 13.5; 8.0; 11.1; 7.3; 4.3	0.0445 sig

Eligibility Criteria

Inclusion criteria

Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm

Exclusion criteria

Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00798161). 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.