A randomised double-blind, placebo-controlled, 3 parallel group study investigating the efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing regimen of maximal metformin therapy in patients with type 2 diabetes mellitus and insufficient glycemic control

Phase 1

Conditions: Type 2 diabetes
MedDRA version: 12.0Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus

Registration Number: EUCTR2009-013549-27-FR

Lead Sponsor: Boehringer Ingelheim France

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 451

Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent.
2. Male and female patients, currently treated with metformin alone, or with metformin
and not more than one other oral antidiabetic drug (antidiabetic therapy may be a
sulphonylurea, meglitinide, DPP-4 inhibitor or a-glucosidase inhibitor and its dose
has to be unchanged for 12 weeks prior to informed consent).
A total daily dose of =1500 mg/day metformin divided into twice daily administration
(e.g., 850 mg bid, 1000 mg bid, 850/1000 mg bid or 500/1000 mg bid) is required for
inclusion into the trial. A patient taking metformin tid can be included if switched to
a bid dosing regimen at the time of informed consent. In this case, the total daily dose
must be maintained (e.g., 500 mg tid to 1000/500 mg bid, 1000/500/500 mg tid to
1000 bid, 500/500/850 mg tid to 1000/850 mg bid). Patients treated with a total daily dose of metformin of less than 1500 mg (e.g., 500 mg bid) can be included in the trial only if the Investigator has documented that the dose is the maximum tolerated dose for that patient. The total daily dosage of metformin needs to be stable for at least 12 weeks prior to randomisation and throughout the duration of the study.
3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening) fulfils the following
criteria: For patients undergoing wash out of previous medication: =7.0 % to
=9.5 %.. For patients not undergoing wash-out of previous medication: =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 =45 kg/m2 (Body Mass Index) at Visit 1a (Screening).
7. Signed and dated written informed consent by date of Visit 1a in accordance with
GCP and local legislation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment with extended release formulations of metformin within 12 weeks prior to
consent.
2. 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).
3. Myocardial infarction, stroke or TIA within 6 months prior to informed consent.
4. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST
(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
determined at Visit 1a.
5. Gastric bypass surgery.
6. Known hypersensitivity or allergy to the investigational product or its excipients or to
the trial background therapy (i.e., metformin).
7. Contraindication to metformin therapy according to local label, for example:
•Renal disease or renal dysfunction (e.g., as specified by product information of locally approved metformin)
•Dehydration by clinical judgement of the investigator
•Acute or chronic metabolic acidosis (present condition in patient history)
•Hereditary galactose intolerance.
8. Renal failure or renal impairment (serum creatinine =1.5 mg/dL [132 µmol/L]) as
determined at Visit 1a (Screening).
9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues/mimetics or insulin
within 3 months prior to informed consent.
10. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) 3 months
prior to informed consent.
11. Alcohol or drug abuse within the 3 months prior to informed consent that would
interfere with trial participation.
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. However, the
use of inhaled steroids (e.g., for asthma, COPD) is not an exclusion as these do not
cause systemic steroid action.
13. Participation in another trial with an investigational drug within 2 months prior to
informed consent.
14. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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