The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo (sitagliptin); Drug: Sitagliptin; Drug: Placebo (linagliptin); Drug: Linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716092

1218.37

2007-007865-19 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Enrollment: 121 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
• Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Exclusion criteria

• Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
• Impaired hepatic function
• Renal insufficiency with a creatinine clearance < 50 mL/min
• Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

121 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.

Treatment:

Drug: Placebo (linagliptin)

Drug: Placebo (sitagliptin)

Linagliptin

Experimental group

Description:

Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.

Treatment:

Drug: Linagliptin

Drug: Placebo (sitagliptin)

Sitagliptin

Active Comparator group

Description:

Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.

Treatment:

Drug: Placebo (linagliptin)

Drug: Sitagliptin