linagliptin in combination with metformin in treatment naive type 2 diabetes.

Phase 1

• Conditions: Type 2 diabetes Mellitus; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-002276-16-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-21
• Last Update Posted: 21 August 2017

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 =10.0% (86 mmol/mol) at Visit 1 (screening)
4.Age =18 and =80 years at Visit 1 (screening)
5.BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening)

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 randomisation
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
6.Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8.Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
9.Known history of pancreatitis and chronic pancreatitis
10.Contraindications to metformin according to the local label
11.Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen in the discretion of investigators, 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 > or = 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 continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation 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 tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
14.Alcohol or drug abuse in the discretion of investigators within the 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 drug 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 secondary 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;Timepoint(s) of evaluation of this end point: 1: 14 weeks