Effect of insulin glargine and lixisenatide versus insulin glargine on brain insulin sensitivity in patients with type 2 diabetes
- Conditions
- MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2018-003557-21-DE
- Lead Sponsor
- niversity Hospital Tuebingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
Subjects meeting all of the following criteria will be considered
for admission to the trial:
• Must be between 18 and 65 years at the time of signing
the informed consent.
• BMI 25-45 kg/m²
• Understand and voluntarily sign an informed consent
document prior to any study related
assessments/procedures.
• Ability to adhere to the study visit schedule and other
protocol requirements.
• Patients with type 2 diabetes mellitus diagnosed for at
least 1 year before the screening visit (visit 1) treated for
at least 3 months prior to visit 1 with only metformin or
metformin and a sodium glucose co-transporter 2
inhibitor, and patients who are not adequately controlled
with this treatment.
• Females of childbearing potential (FCBP) must agree
? to utilize a highly effective forms of contraception
(Pearl index < 1) or practice complete abstinence
from heterosexual contact while participating in
the study (including dose interruptions), and for
at least 28 days after study treatment
discontinuation and must agree to pregnancy
testing during this timeframe
? to abstain from breastfeeding during study
participation and 28 days after study drug
discontinuation.
• Males must agree
? to use a latex condom during any sexual contact
with FCBP while participating in the study and for
28 days following discontinuation from this study,
even if he has undergone a successful vasectomy
? to refrain from donating semen or sperm while
participating in this study and for 28 days after
discontinuation from this study treatment.
• All subjects must agree to refrain from donating blood
while on study drug and for 28 days after discontinuation
from this study treatment.
• All subjects must agree not to share medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following criteria will not be included in the trial:
• HbA1c at screening visit less than 7.5% or more than 12% for patients previously treated with metformin alone or with metformin and a second oral anti-diabetic treatment.• Women during pregnancy and lactation.• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products. This includes iGlarLixi, insulin glargine, and human nasal insulin.
• Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucoselowering
agents during 3 months before screening • History of discontinuation of a previous treatment with a GLP-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine +lixisenatide fixed ratio combination or has previously received lixisenatide.
• Any contraindication to metformin use, according to local labeling. • Use of weight loss drugs within 3 months prior to screening visit. • Within the last 6 months prior to screening visit: myocardial infarction, unstable angina, or heart failure
requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be
performed during the study period. • History of stroke. • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 160 mmHg or diastolic blood pressure above 90 mmHg) at screening visit. • At screening visit, Body Mass Index (BMI) less than or equal to 25 or above 45 kg/m². • At screening visit ALT or AST more than 3 ULN. • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). • Exclusion Criteria for randomization at the end of the screening period: o HbA1c less than 7.5% or above 12%. o Amylase and/or lipase more than 3 ULN. o Calcitonin above or equal to 20 pg/mL (5.9pmol/L). • Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study. • Known malformation of the central nervous system• Persons working nightshift• Treatment with drugs with central nervous actions or systemic steroid therapy • Any relevant (according to investigator’s judgment) cardiovascular disease, e.g. myocardial infarction, acute coronary syndrome, unstable angina pectoris,PTCA, heart failure (NYHA II-IV), planned coronary,carotid or peripheral artery revascularisation procedures to be performed during the study period.
• Indication of liver disease, as per medical history or defined by serum levels of either Alanine,Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or Alkaline Phosphatase above 3 x upper limit of normal (ULN) as determined during screening.• Alcohol abuse, defined as more than 20 gr/day • Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) = 60 ml/min (MDRD formula) as determined duri
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method