Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

Official Title: “12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin”

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Intervention(s) in this Clinical Trial

• Drug: linagliptin low dose
  • patient to receive tablets containing low dose linagliptin twice daily
• Drug: placebo
  • patient to receive placebo tablet(s) matching linagliptin
• Drug: linagliptin medium dose
  • patient to receive a tablet containing medium dose linagliptin once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: linagliptin low dose
  • linagliptin low dose twice daily
• Placebo Comparator: placebo
  • placebo matching linagliptin
• Experimental: linagliptin medium dose
  • linagliptin medium dose once daily

Primary Measures

• HbA1c Change From Baseline at Week 12
  • Time Frame: Baseline and week 12
    Safety Issue?: No

Secondary Measures

• HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
  • Time Frame: Baseline and week 6
    Safety Issue?: No
• HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
  • Time Frame: Baseline and week 12
    Safety Issue?: No
• FPG Change From Baseline at Week 12
  • Time Frame: Baseline and week 12
    Safety Issue?: No
• FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
  • Time Frame: Baseline and week 6
    Safety Issue?: No
• FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
  • Time Frame: Baseline and week 12
    Safety Issue?: No
• Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• Percentage of Patients With Rescue Therapy
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion criteria

• 1. Diagnosis of type 2 diabetes mellitus.
• 2. Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
• 3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
• 4. Body Mass Index (BMI) </=45 kg/m2.

Exclusion criteria

• 1. Treatment with extended release metformin.
• 2. Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).
• 3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
• 4. Impaired hepatic or renal function, or gastric bypass surgery.
• 5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
• 6. Current treatment with systemic steroids or change in dosage of thyroid hormones.
• 7. Alcohol or drug abuse within 3 months of informed consent.
• 8. Participation in another trial with investigational drug within 2 months prior to informed consent.
• 9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01012037

Study ID Number: 1218.62

ClinicalTrials.gov Identifier: NCT01012037

Health Authority: Belgium: Federal Agency for Medicinal and Health Products