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

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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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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