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

Phase 1

Completed

• Conditions: Diabetes; Type 2 Diabetes Mellitus
• Interventions: Drug: insulin degludec; Drug: Insulin icodec; Drug: placebo

• Registration Number: NCT02148861
• Lead Sponsor: Novo Nordisk A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-05-23
• Study Start: 2014-05-26
• Study First Posted: 2014-05-28
• Primary Completion: 2015-06-01
• Study Completion: 2015-06-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin degludec + placebo	placebo	Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
Insulin 287 + placebo	placebo	Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
Insulin degludec + placebo	insulin degludec	Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
Insulin 287 + placebo	Insulin icodec	Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
area under the glucose infusion rate - time curve at steady-state	At Day 31 and day 35

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany