Phase 3
Completed N=1,055
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00602472 ↗Enrolled (actual)
1,055
Serious AEs
3.3%
Results posted
Jun 2011
Primary outcomePrimary: HbA1c Change From Baseline to Week 24 — -0.10; -0.72 Percent — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea 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 |
-0.10; -0.72 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 6 |
-0.18; -0.67 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 12 |
-0.15; -0.84 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline to Week 18 |
-0.11; -0.81 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 24 |
8.1; -4.6 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 6 |
6.3; -11.5 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 12 |
6.2; -9.5 | <0.0001 sig |
| SECONDARY FPG Change From Baseline to Week 18 |
7.4; -4.7 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24 |
8.1; 29.2 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c < 7.0% at Week 24 |
9.2; 31.2 | — |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 24 |
4.2; 13.1 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c<6.5% at Week 24 |
4.2; 13.1 | — |
| SECONDARY Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24 |
30.2; 58.2 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
- Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and /= 18 and /= 1.5 mg/dl) as determined at Visit 1a
- Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
- Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
- Treatment with insulin within 3 months prior to the date of informed consent
- Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
- Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
- Pre-menopausal women (last menstruation </= 1 year prior to the date of 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 periodic pregnancy testing during their 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.
- Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
- Dehydration (as confirmed by the Investigators clinical opinion)
- Current acute or chronic metabolic acidosis
Data sourced from ClinicalTrials.gov (NCT00602472). 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.