linagliptin in combination with metformin in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control.
- Conditions
- Type 2 diabetes MellitusMedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2011-002276-16-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1360
1.Diagnosis of Type 2 diabetes mellitus prior to informed consent;
2. Male and female patients on diet and excise regimen who are drug naive, defined as abesense of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
3. Glycoslylated haemoglobin A1c (HbA1c) >/= 6.5% (48 mmol/mol) to 4. Age>/=18 and 5. Body Mass Index(BMI)6. Signed and dated written informed consent by date of visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
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
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. Myocaridial infarction,stroke or Transient ischemia attack (TIA) within 3 months prior to informed consent;
4. Indication of liver disease/Impaired hepatic function, defined by serum levels of either Aspartate aminotransferase (ALT or SGPT), alanine aminotransferase (AST or SGOT), or alkaline phosphatase above 3 x uppler limit of normal (ULN) as determined at visit 1,
5. Impaired renal function fuction, defined as eGFR< 60ml/min (severe renal impairement, modification of diet in renal disease (MDRD) formula) as determined at 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. Contraindications to moetformin according to the local label
10. 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 regimen etc) leading to unstable body weight
12. 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. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
13. 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 drug intake
14. Participation in another trial with application of any investigational drug within 30 days prior to informed consent
15. Any other clinical condition that would jeopardize patients safety while participating in this trial
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;Timepoint(s) of evaluation of this end point: 1: 14 weeks
- Secondary Outcome Measures
Name Time Method