Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Prevention
Treatment
Midazolam
Placebo
LY3549492
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with T2DM for at least 6 months, as defined by the American DiabetesAssociation or the World Health Organization,
treated with diet and exercise and stable dose(s) of metformin, with or without 1 other oral antidiabetic medication (OAM) at stable dose, 3 months prior tostudy entry
If taking statins, must be on stable statin treatment without a history ofstatin myopathy for at least 3 months
with a glycated hemoglobin (HbA1c) value of
greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.5% at screening on metformin only and
≥6.5% and ≤9.5% on metformin in combination with OAMs other thanmetformin.
Body weight ≥45.0 kilograms (kg) and body mass index within the range of 18.5 to 45.0 kilogram per square meter (kg/m²) (inclusive).
Stable body weight for the 3 months prior to screening
Women must not be of childbearing potential.
Exclusion
Exclusion Criteria:
Women of childbearing potential.
Have type 1 diabetes mellitus, known latent autoimmune diabetes in adults, or havehad an episode of ketoacidosis or hyperosmolar state requiring hospitalization in 6months prior to screening.
Have active proliferative diabetic retinopathy, diabetic maculopathy, or severenonproliferative diabetic retinopathy that requires acute treatment
Present with uncontrolled comorbid conditions commonly associated with diabetes (forexample, hypertension, hypercholesterolemia) or have had changes to medication forthose conditions within 1 month prior to screening.
Have had an episode of severe hypoglycemia, as defined by the occurrence ofneuroglycopenic symptoms requiring the assistance of another person for recovery,within 6 months prior to screening visit, or have a history of hypoglycemiaunawareness or poor recognition of hypoglycemic symptoms. Any participant that theinvestigator feels will not be able to communicate an understanding of hypoglycemicsymptoms and the appropriate treatment of hypoglycemia should also be excluded.
Have a known clinically significant gastric emptying abnormality (for example,severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastricbypass (bariatric) surgery or restrictive bariatric surgery (for example, gastricbanding ), and/or device-based therapy for obesity, or have had device removalwithin the past 6 months.
Have active or symptomatic gastric ulceration or chronic gastritis.
Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation oran abnormal thyroid stimulating hormone (for those with current or previous thyroidhistory) that, in the opinion of the investigator, would pose a risk to participantsafety.
Have known definitive diagnosis of autonomic neuropathy as evidenced by neuropathicurinary retention, resting tachycardia, orthostatic hypotension, or diabeticdiarrhea.
Have obesity induced by other endocrine disorders such as Cushing's syndrome orPrader-Willi syndrome.
A history of additional risk factors for Torsades de Pointes (for example, heartfailure, hypokalemia, family history of long QT syndrome, use of concomitantmedications that prolong the QT/QTc interval).
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in theopinion of the investigator, increases the risks associated with participating inthe study or may confound ECG data analysis
Have a significant history (within the past 6 months) of or current comorbiditiescapable of altering the absorption, metabolism, or elimination of drugs; ofconstituting a risk when taking the study drug; or of interfering with theinterpretation of data. These include cardiovascular, respiratory diseases, renaldiseases, gastrointestinal (GI) diseases, hematological diseases, neurologicaldiseases, dermatological diseases
Have a history or presence of pancreatitis (history of chronic pancreatitis oridiopathic acute pancreatitis), elevation in serum amylase or lipase levels (>2.5fold the upper limit of normal [ULN]).
Have a personal or family history of medullary thyroid carcinoma or multipleendocrine neoplasia syndrome type 2.
Have a serum calcitonin level of
≥20.0 picograms per milliliter (pg/mL) at screening, if estimated glomerularfiltration rate is ≥60 milliliters per minute per 1.73 m² (mL/min/1.73 m²)
≥35.0 pg/mL at screening, if estimated glomerular filtration rate is <60mL/min/1.73 m²
Have known liver disease, obvious clinical signs or symptoms of liver disease, acuteor chronic hepatitis, or have elevations in aminotransferases (alanine transaminase [ALT] and aspartate aminotransferase [AST]) greater than 2 × ULN.
Have total bilirubin level (TBL) >1.5 × ULN (except for participants diagnosed withGilbert's syndrome).
Study Design
Connect with a study center
Profil Institut für Stoffwechselforschung
Neuss, 41460
GermanySite Not Available
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