Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00915772

First received: June 2, 2009

Last updated: April 29, 2014

Last verified: April 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

June 2, 2009

Last Updated Date

April 29, 2014

Start Date ^ICMJE

June 2009

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of Patients With Adverse Events (AEs) [ Time Frame: 54 weeks ]
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) [ Time Frame: 54 weeks ]
Baseline is defined as Visit 1 of 1218.52.
Change From Baseline at Week 54 in Pulse Rate [ Time Frame: 54 weeks ]
Baseline is defined as Visit 1 of 1218.52.
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology [ Time Frame: 54 weeks ]
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry [ Time Frame: 54 weeks ]
ULN means upper limit of normal
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE [ Time Frame: Baseline and drug stop (up to 54 weeks) + 7 days ]
Frequency of patients with adverse events by treatment, primary system organ class and preferred term

Original Primary Outcome Measures ^ICMJE

Incidence and intensity of AEs; Withdrawal due to AEs; Clinically relevant new or worsening findings in physical examination and 12lead ECG as reported as AE; Changes from baseline in vital signs and clinical laboratory assessments [ Time Frame: 54 weeks ]

Change History

Complete list of historical versions of study NCT00915772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in HbA1c From Baseline Over Time [ Time Frame: 54 weeks ]
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.
Number of Patients With HbA1c <7.0% After 54 Weeks [ Time Frame: 54 weeks ]
Number of Patients With HbA1c <6.5% Over Time [ Time Frame: 54 weeks ]
Number of Patients With HbA1c of at Least <0.5% Over Time [ Time Frame: 54 weeks ]
Change in FPG From Baseline Over Time [ Time Frame: 54 weeks ]
Baseline is defined as visit 1 of 1218.52.
Number of Patients With Rescue Therapy [ Time Frame: 54 weeks ]
Change in HbA1c From Baseline Over Time [ Time Frame: 78 weeks ]
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).

Original Secondary Outcome Measures ^ICMJE

Change from baseline in HbA1c and FPG after 54 weeks of treatment and FPG by visit over time; Occurrance of a treat to target response that is an HbA1c under treatment of <7% and < 6.5% after 54 weeks of treatment; HbA1c reduction [ Time Frame: 54 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

Official Title ^ICMJE

Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

Brief Summary

A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Linagliptin + metformin
Linagliptin tablet low dose + metformin tablet 500 mg bid
Drug: Linagliptin+metformin
Linagliptin low dose tablet + metformin 1000 mg tablet bid
Drug: Metformin
Metformin 1000 mg tablet bid

Study Arms

Experimental: Linagliptin + metformin bid
Linagliptin low dose + metformin 500 mg, bid

Intervention: Drug: Linagliptin + metformin
Experimental: Linagliptin+ metformin bid
Linagliptin low dose + metformin 1000 mg bid

Intervention: Drug: Linagliptin+metformin
Active Comparator: Metformin bid
Metformin 1000 mg bid

Intervention: Drug: Metformin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

567

Completion Date

Not Provided

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Signed and dated written informed consent, at the latest by the date of Visit 1
Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)

Exclusion criteria:

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46
Pre-menopausal women (last menstruation equal or less than 1 year prior to signing 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 and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation
Drug abuse that in the opinion of the investigator would interfere with trial participation
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russian Federation, Sweden, Tunisia, Ukraine

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00915772

Other Study ID Numbers ^ICMJE

1218.52
2008-008494-59 ( EudraCT Number: EudraCT )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

April 2014

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

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