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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03292185

U1111-1155-0990 (Other Identifier)

NN9068-4139

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 6 patient groups

IDeglira-IDeg-Liraglutide

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide

IDeglira-Liraglutide-IDeg

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide

IDeg-Liraglutide-IDeglira

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide

IDeg-IDeglira-Liraglutide

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide

Liraglutide-IDeg-IDeglira

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide

Liraglutide-IDeglira-IDeg

Experimental group

Description:

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

Treatment:

Drug: insulin degludec

Drug: liraglutide

Drug: insulin degludec/liraglutide