Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Source: ClinicalTrials.gov NCT00819091 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 |
-0.07; -0.54 | < 0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 18 |
-1.8; -8.2 | 0.2406 |
| SECONDARY Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 |
3.7; 15.2; 96.3; 84.8 | 0.0065 sig |
| SECONDARY Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 |
2.4; 5.7; 97.6; 94.3 | 0.2431 |
| SECONDARY Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 |
22; 57.6; 78.0; 42.4 | 0.0001 sig |
| SECONDARY Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 |
-0.02; -0.43 | <0.0001 sig |
| SECONDARY Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 |
-0.11; -0.61 | <0.0001 sig |
| SECONDARY Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 |
-0.08; -0.55 | 0.0002 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 6 |
-7.6; -13.5 | 0.197 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
4.1; -10.3 | 0.0105 sig |
Eligibility Criteria
Inclusion criteria
Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug
Exclusion criteria
Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Data sourced from ClinicalTrials.gov (NCT00819091). 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.