Phase 3
Completed N=133
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Source: ClinicalTrials.gov NCT00800683 ↗Enrolled (actual)
133
Serious AEs
39.1%
Results posted
Feb 2012
Primary outcomePrimary: HbA1c Change From Baseline at Week 12 — -0.15; -0.76 Percent — p=< 0.0001
Summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 12 |
-0.15; -0.76 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 52 |
0.01; -0.71 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 18 |
0.04; -0.57 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 24 |
0.04; -0.64 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 30 |
0.04; -0.67 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 36 |
0.03; -0.72 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 42 |
-0.08; -0.73 | < 0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 48 |
-0.04; -0.77 | < 0.0001 sig |
| SECONDARY The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment |
0; 6.1 | 0.1199 |
| SECONDARY The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment |
9.8; 18.0 | 0.2225 |
| SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 |
11.3; 27.3 | 0.8927 |
| SECONDARY FPG Change From Baseline at Week 12 |
-7.08; -8.81 | 0.8802 |
| SECONDARY FPG Change From Baseline at Week 18 |
-12.72; -14.97 | 0.7848 |
| SECONDARY FPG Change From Baseline at Week 24 |
-6.22; -16.93 | 0.1878 |
| SECONDARY FPG Change From Baseline at Week 30 |
-14.54; -10.12 | 0.5781 |
| SECONDARY FPG Change From Baseline at Week 36 |
-11.29; -20.53 | 0.2954 |
| SECONDARY FPG Change From Baseline at Week 42 |
-13.25; -8.88 | 0.5984 |
| SECONDARY FPG Change From Baseline at Week 48 |
-10.52; -3.45 | 0.4085 |
| SECONDARY FPG Change From Baseline at week52 |
-6.81; -5.47 | 0.8698 |
| SECONDARY Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time |
11; 17; 29; 24; 33; 32 | — |
| SECONDARY Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG |
1; 0; 1; 0; 1; 1 | — |
Eligibility Criteria
Inclusion criteria
- Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
- Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
- Age 18 or over and not older than 80 years
Exclusion criteria
- Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- Unstable or acute congestive heart failure
Data sourced from ClinicalTrials.gov (NCT00800683). 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.