linagliptin in combination with metformin in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1360

Inclusion Criteria

1. Diagnosis of T2DM prior to informed consent; 2. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral antidiabetic drugs (OAD) or any injectable antidiabetic therapies for at least 12 weeks prior to randomization; 3. HbA1c of >/=7.0% (53 mmol/mol) and /=18 and Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1.Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day);
2.Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization;
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
4. Indication of liver disease / 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 during screening and/or run-in phase 5. Impaired renal function, defined as eGFR<60 ml/min (MDRD formula) as determined during screening or run-in phase;
5. Impaired renal function, defined as eGFR<60 ml/min (MDRD formula) as determined during screening or run-in phase;
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malaborption;
7. Medical history of Cancer(except for basal cell carcinoma) and/or treatment for cancer within the last 5 years;
8. Blood dyscrasia or any other disorders causing hemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, hamolytic anemia);
9. Known history of pancreatitis and chronic pancreatitis;
10. Contraindications to moetformin according to the local label;
11. Treatment with anti-obesity drugs 3 months prior to informed consent or any otehr treatment at the time of screening (i.e. surgery, aggressive diet regimenm etc.) leading to unstable body weight;
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 or any other uncontrolled endocrine disorder except T2DM;
13. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
a. are nursing or pregnant or
b. are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to contiune using this method throughout the study and do not agree to submit to periodic pregancy testing during parcipation in the trial or who do not agree to continue contraception for at least 30 days after the last dose of study drug. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
14. Alcohol or drug abuse within 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 drgu intake;
15. Participation in another trial with application of any investigational drug within 30 days prior to informed consent;
16. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial according to investigator’s judgement;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The change from baseline in HbA1c after 14 weeks treatment;Secondary Objective: Key sencondary objectives are to assess whether the combination therapy (once daily) has improved tolerability to gastrointestinal (GI) side effects over metformin alone (twice daily), by comparing the composite endpoint of occurrence of treat to target response, defined HbA1c<7.0% and no occurence of moderate or severe metformin pre-specified GI side effects during 14 weeks treatment; and the occurrence of metformin pre-specified moderate or severe GI side effects during 14 weeks treatment.;Primary end point(s): 1: The change from baseline in Glycosylated Hemoglobin A1c (HbA1c) after 14 weeks treatment<br><br>;Timepoint(s) of evaluation of this end point: 1: 14 weeks<br>

Secondary Outcome Measures

Name	Time	Method

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