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Completed

NCT Number: NCT01012037

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1218.62.32003 Boehringer Ingelheim Investigational Site, De Pinte, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of type 2 diabetes mellitus.
  • 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.
  • Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
  • Body Mass Index (BMI) </=45 kg/m2.

Exclusion criteria

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

Treatment and study plan

linagliptin low dose

Drug

patient to receive tablets containing low dose linagliptin twice daily

Placebo

Drug

patient to receive placebo tablet(s) matching linagliptin

linagliptin medium dose

Drug

patient to receive a tablet containing medium dose linagliptin once daily

Primary outcomes

  1. HbA1c Change From Baseline at Week 12

    Time frame: Baseline and week 12

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.

Secondary outcomes

  1. HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis

    Time frame: Baseline and week 6

    Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.

  2. HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis

    Time frame: Baseline and week 12

    Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.

  3. FPG Change From Baseline at Week 12

    Time frame: Baseline and week 12

    Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.

  4. FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis

    Time frame: Baseline and week 6

    Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.

  5. FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis

    Time frame: Baseline and week 12

    Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.

  6. Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12

    Time frame: Week 12

    Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.

  7. Percentage of Patients With Rescue Therapy

    Time frame: 12 weeks

    Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.

  8. The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment

    Time frame: 12 weeks

    Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.

  9. The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment

    Time frame: 12 weeks

    Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

Important dates

Study start
2009
Primary completion
2010
First posted
Nov 11, 2009
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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