Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
With
Eli Lilly and Company
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated written informed consent
Male or female patient receiving insulin for treatment of T1DM for at least 12 months
C-peptide \< 1.5 ng/mL
Age 18 to 65 years
HbA1c of 7.5% to 10.5%
Multiple daily injections (MDI) of any type of insulin
Willing to follow an established and individualized carbohydrate counting method and an insulin administration algorithm
Body Mass Index of 18.5 to 35.0 kg/m2
Estimated glomerular filtration rate 60 to 150 mL/min/1.73 m²
Able and willing to perform study assessments according to investigator's judgement
Compliance with trial drug administration 80% to 120% during run-in period
Willing not to take any paracetamol containing drugs during the trial
You may not be if
Acute symptomatic urinary tract infection or genital infection, chronic or recurrent cystitis
History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
Pancreas, pancreatic islet cells or renal transplant recipient
Type 1 diabetes mellitus treatment with any other antihyperglycaemic drug except insulin within last 3 months or history of clinically relevant hypersensitivity
Occurrence of hypoglycaemia that required hospitalization or treatment by an emergency physician or paramedic within last 3 months
Hypoglycaemia unawareness or frequent episodes of unexplained hypoglycaemia
Occurrence of diabetic ketoacidosis that required hospitalization or treatment by an emergency physician or paramedic within last 12 months
History of macrovascular disease including cardiovascular, cerebrovascular and peripheral artery disease
Autonomic neuropathy with gastroparesis
Brittle diabetes
Liver disease
Treatment with anti-obesity drugs, surgery or aggressive diet regimen leading to unstable body weight
Treatment with systemic corticosteroids
Change in dose of thyroid hormones within last 6 weeks or planned change or initiation of such a therapy
Medical history of cancer or treatment for cancer in the last five years
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
Alcohol or drug abuse that would interfere with trial participation or any ongoing clinical condition that would jeopardize patient's or site personnel's safety or study compliance
Intake of an investigational drug in another trial within last 30 days
Not able to understand and comply with study requirements
Pre-menopausal women who are nursing or pregnant or of child-bearing potential and are not practising an acceptable method of birth control
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