Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Linagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214239

1218.66

Details and patient eligibility

About

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 in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.

Enrollment

300 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment naive or treated with one antidiabetic medication. Antidiabetic therapy has to be unchanged for 6 weeks prior to the informed consent
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):

For patients undergoing wash out of previous medication: HbA1c =7.0to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
Age = 18 and < 80 years at Visit 1a (Screening)
BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function, defined by serum levels of either Alanine transaminase(SGPT), Aspartate transaminase(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
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)
Known hypersensitivity or allergy to the investigational product or its excipients
Treatment with more than one antidiabetic drug within 6 weeks prior to informed consent
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with Glucagon-like peptide 1(GLP-1) analogues (e.g. exenatide) , Dipeptidyl-Peptidase 4(DPP-IV) inhibitor within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent
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.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
Dehydration by clinical judgement of the investigator
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance