Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

July 25, 2016 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin Therapy

In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • 1218.65.86007 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 1218.65.86011 Boehringer Ingelheim Investigational Site
      • Dalian, China
        • 1218.65.86008 Boehringer Ingelheim Investigational Site
      • Fuzhou, China
        • 1218.65.86010 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1218.65.86014 Boehringer Ingelheim Investigational Site
      • Hefei, China
        • 1218.65.86005 Boehringer Ingelheim Investigational Site
      • Hefei, China
        • 1218.65.86006 Boehringer Ingelheim Investigational Site
      • Nanjing, China
        • 1218.65.86012 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1218.65.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1218.65.86002 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1218.65.86003 Boehringer Ingelheim Investigational Site
      • Suzhou, China
        • 1218.65.86004 Boehringer Ingelheim Investigational Site
      • Wenzhou, China
        • 1218.65.86015 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 1218.65.86009 Boehringer Ingelheim Investigational Site
      • Yangzhou, China
        • 1218.65.86013 Boehringer Ingelheim Investigational Site
      • Johor Bahru,, Malaysia
        • 1218.65.60002 Boehringer Ingelheim Investigational Site
      • Kelantan, Malaysia
        • 1218.65.60001 Boehringer Ingelheim Investigational Site
      • Marikina, Philippines
        • 1218.65.63001 Boehringer Ingelheim Investigational Site
      • San Juan, Philippines
        • 1218.65.63002 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).
  2. Diagnosis of type 2 diabetes prior to informed consent
  3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):

    For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%

  4. Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
  5. Age = 18 and < 80 years at Visit 1a (Screening)
  6. BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
  7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

  1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
  2. Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
  3. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
  4. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
  5. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
  6. Treatment with an injectable Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent
  7. Treatment with insulin within 3 months prior to informed consent
  8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent.
  9. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
  10. Participation in another trial with an investigational drug within 2 months prior to informed consent
  11. 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 and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  13. Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
  14. Dehydration by clinical judgement of the investigator
  15. Unstable or acute congestive heart failure
  16. Acute or chronic metabolic acidosis (present in patient history)
  17. Hereditary galactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linagliptin
once a day
once a day
Placebo Comparator: placebo
once a day
once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 24
Time Frame: Baseline and at week 24
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline and at week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 6
Time Frame: Baseline and at week 6
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline and at week 6
HbA1c Change From Baseline at Week 12
Time Frame: Baseline and at week 12
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline and at week 12
HbA1c Change From Baseline at Week 18
Time Frame: Baseline and at week 18
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline and at week 18
FPG Change From Baseline at Week 12
Time Frame: Baseline and at week 12
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Baseline and at week 12
FPG Change From Baseline at Week 18
Time Frame: Baseline and at week 18
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Baseline and at week 18
Number of Patients With HbA1c < 7.0%
Time Frame: baseline and at week 24
Number of patients with HbA1c < 7.0% at week 24
baseline and at week 24
Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.
Time Frame: baseline and at week 24
Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.
baseline and at week 24
Number of Patients With HbA1c < 6.5%
Time Frame: baseline and at week 24
Number of patients with HbA1c < 6.5% at week 24
baseline and at week 24
Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.
Time Frame: baseline and at week 24
Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.
baseline and at week 24
Number With HbA1c at Least Lowering 0.5%
Time Frame: baseline and at week 24
Number with HbA1c at least 0.5% lowering from baseline at week 24
baseline and at week 24
HbA1c Change From Baseline at Week 24(Chinese Only)
Time Frame: Baseline and at 24 weeks
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline and at 24 weeks
FPG Change From Baseline at Week 24
Time Frame: Baseline and at week 24
Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.
Baseline and at week 24
FPG Change From Baseline at Week 6
Time Frame: Baseline and at week 6
Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Baseline and at week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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