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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148861
• Other study ID #: NN1436-4057
• Secondary ID: 2013-001180-22U1
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2014
• Est. completion date: June 1, 2015

Study information

• Verified date: March 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
• insulin degludec
Administered once-daily subcutaneously (s.c., under the skin) for 35 days
• placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events		From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65)
Secondary	Area under the steady-state serum insulin 287 concentration-time curve		During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)
Secondary	area under the glucose infusion rate - time curve at steady-state		At Day 31 and day 35

External Links

•   Clinical Trials at Novo Nordisk