A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects

NCT03292185 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9068-4139U1111-1155-0990
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Area under the serum insulin degludec concentration time curve

  Calculated based on insulin degludec concentration in serum

  From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours

• Area under the plasma liraglutide concentration time curve

  Calculated based on liraglutide concentration in plasma

  from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours

Secondary Outcomes (11)

• Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose

  0 hours to 120 hours

• Maximum observed serum insulin degludec concentration

  0 hours to 120 hours

• Time to maximum serum insulin degludec concentration

  0 hours to 120 hours

• Terminal elimination half-life for insulin degludec

  0 hours to 120 hours

• Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose

  0 hours to 72 hours

Study Arms (6)

IDeglira-IDeg-Liraglutide

EXPERIMENTAL

Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

IDeglira-Liraglutide-IDeg

EXPERIMENTAL

Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

IDeg-Liraglutide-IDeglira

EXPERIMENTAL

Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

IDeg-IDeglira-Liraglutide

EXPERIMENTAL

Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

Liraglutide-IDeg-IDeglira

EXPERIMENTAL

Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

Liraglutide-IDeglira-IDeg

EXPERIMENTAL

Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec

Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide

Interventions

insulin degludec/liraglutide DRUG

Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.

IDeg-IDeglira-Liraglutide; IDeg-Liraglutide-IDeglira; IDeglira-IDeg-Liraglutide; IDeglira-Liraglutide-IDeg; Liraglutide-IDeg-IDeglira; Liraglutide-IDeglira-IDeg

insulin degludec DRUG

17 U Insulin Degludec, single dose administration under the skin in the thigh.

IDeg-IDeglira-Liraglutide; IDeg-Liraglutide-IDeglira; IDeglira-IDeg-Liraglutide; IDeglira-Liraglutide-IDeg; Liraglutide-IDeg-IDeglira; Liraglutide-IDeglira-IDeg

liraglutide DRUG

0.6 mg Liraglutide, single dose administration under the skin in the thigh

IDeg-IDeglira-Liraglutide; IDeg-Liraglutide-IDeglira; IDeglira-IDeg-Liraglutide; IDeglira-Liraglutide-IDeg; Liraglutide-IDeg-IDeglira; Liraglutide-IDeglira-IDeg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator
• Age between 18 to 45 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive)
• Body weight at least 50.0 kg
• Fasting plasma glucose less than 6.1 mmol/L (110 mg/dL)

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive methods throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
• Donation of any blood or plasma in the past month or in excess of 400 mL within the 90 days preceding screening or surgery or trauma with more than 400 mL blood loss within the 90 days preceding screening
• History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes and recurrent hypoglycaemia), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial result, as judged by the investigator
• Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (mega-dose vitamin therapy not allowed, dose judged by the investigator) within 2 weeks prior to screening

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

IDegLira; insulin degludec; Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-period complete cross-over, six treatment sequences

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: September 29, 2017
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)