A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes

NCT04136067 | Completed Phase 1

• 3 other identifiers: NN1965-4457U1111-1227-86832019-000754-58
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events (AEs)

  Number of events

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)

Secondary Outcomes (3)

• Number of treatment-emergent hypoglycaemic episodes

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)

• Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state

  From 0 to 24 hours after IMP administration at day 6 (visit 2)

• Maximum observed serum NNC0268-0965 concentration after the last dose

  From 0 to 24 hours after IMP administration at day 6 (visit 2)

Study Arms (2)

NNC0268-0965

EXPERIMENTAL

Participants will receive NNC0268-0965

Drug: NNC0268-0965

Insulin glargine

ACTIVE COMPARATOR

Participants will receive insulin glargine

Drug: insulin glargine

Interventions

NNC0268-0965 DRUG

One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days

NNC0268-0965

insulin glargine DRUG

One daily dose of 3.0 nmol/kg administered s.c. for 6 days

Insulin glargine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
• Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
• Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
• HbA1c equal to or below 9.5%

You may not qualify if:

• Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
• Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: October 29, 2019
• Primary Completion: August 23, 2020
• Study Completion: August 23, 2020
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)