Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01708902
First received: October 16, 2012
Last updated: May 13, 2014
Last verified: May 2014

October 16, 2012
May 13, 2014
October 2012
April 2014   (final data collection date for primary outcome measure)
The change from baseline in HbA1c after 24 weeks of treatment (for both in main group and additional parallel group). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01708902 on ClinicalTrials.gov Archive Site
  • The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % and < 6.5% after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The frequency of patients with use of rescue therapy during 24 week treatment period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant changes in clinical laboratory values from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Test the occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % and < 6.5% after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Test the occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Test the change in FPG from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Test the change of Fasting Plasma Glucose(FPG) by visit over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Test the use of rescue therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Test the change of Postprandial Glucose(PPG) from baseline after 24 weeks of treatment (substudy in main group) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse events,Hypoglycaemic events and Protocol-specified significant adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: linagliptin2.5mg/metformin1000mg
    linagliptin2.5mg/metformin1000mg BID
  • Drug: linagliptin 5mg
    linagliptin 5mg once daily
  • Drug: Metformin 500mg
    Metformin 500mg BID
  • Drug: linagliptin2.5mg/metformin500mg
    linagliptin2.5mg/metformin500mg BID
  • Drug: Metformin 1000mg
    Metformin 1000mg BID
  • Experimental: linagliptin2.5mg / metformin500mg BID
    patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID
    Interventions:
    • Drug: linagliptin 5mg
    • Drug: Metformin 500mg
  • Experimental: linagliptin2.5mg / metformin1000mg BID
    patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID
    Interventions:
    • Drug: linagliptin 5mg
    • Drug: Metformin 1000mg
  • Active Comparator: metformin 500mg BID
    patient to receive a tablet containing metformin 500mg BID
    Intervention: Drug: linagliptin2.5mg/metformin500mg
  • Active Comparator: metformin 1000mg BID
    patient to receive a tablet containing metformin 1000mg BID
    Intervention: Drug: linagliptin2.5mg/metformin1000mg
  • Active Comparator: linagliptin 5 mg QD
    patient to receive a tablet containing linagliptin 5mg once daily
    Interventions:
    • Drug: linagliptin2.5mg/metformin1000mg
    • Drug: linagliptin2.5mg/metformin500mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
876
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent
  2. Male and female patients on diet and exercise regimen who are drug-naïve
  3. Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/= 11.0 % for the additional parallel group
  4. Age >/= 18 and </= 80 years at Visit 1a (Screening)
  5. Body Mass Index(BMI)</ = 40 kg/m2 at Visit 1a (Screening)
  6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
  2. In main group, the patients with investigational medicinal product(IMP) compliance < 80 % or >120 % during 2 weeks placebo run in period
  3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
  4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a
  5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
  6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
  7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
  8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
  9. Pre-menopausal women (last menstruation </= 1 year prior to 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
  10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min
  12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  13. Dehydration by clinical judgement of the investigator
  14. Clinical detected unstable or acute congestive heart failure
  15. Acute or chronic metabolic acidosis (present in patient history)
  16. Hereditary galactose intolerance
  17. Known history of pancreatitis and chronic pancreatitis
  18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
  19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Malaysia,   Philippines,   Vietnam,   China
 
NCT01708902
1288.18
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP