Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01708902
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naïve
3. Glycosylated haemoglobin A1c (HbA1c) at V1a \>/=7.5 %\<11% for main group and HbA1c \>/= 11.0 % for the additional parallel group
4. Age \>/= 18 and \</= 80 years at Visit 1a (Screening)
5. Body Mass Index(BMI)\</ = 40 kg/m2 at Visit 1a (Screening)
6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation
Exclusion criteria:
1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
2. In main group, the patients with investigational medicinal product(IMP) compliance \< 80 % or \>120 % during 2 weeks placebo run in period
3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a
5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
7. Alcohol or drug abuse 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 in the opinion of the investigator.
8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
9. 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
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) \< 60 ml/min
12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
13. Dehydration by clinical judgement of the investigator
14. Clinical detected unstable or acute congestive heart failure
15. Acute or chronic metabolic acidosis (present in patient history)
16. Hereditary galactose intolerance
17. Known history of pancreatitis and chronic pancreatitis
18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01708902
Study Brief:
Protocol Section:
NCT01708902