A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent

• Females of no childbearing potential [if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L]

• Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products

• Receipt of any investigational medicinal products within 3 months before screening

• Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening