A Study to Look at How Safe NNC0268-0965 is in People Wit... | NCT04136067

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

NCT04136067

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Sep 8, 2022Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Diabetes Mellitus, Type 2

Interventions

NNC0268-0965
insulin glargine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1227-8683	Other Identifier	World Health Organization (WHO)
2019-000754-58	Registry Identifier	European Medicines Agency (EudraCT)

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2019Actual

Primary Completion Date

Aug 23, 2020Actual

Completion Date

Aug 23, 2020Actual

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Oct 21, 2019

First Posted Date

Oct 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2022

Last Update Posted Date

Sep 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC0268-0965	Experimental	Participants will receive NNC0268-0965	Drug: NNC0268-0965
Insulin glargine	Active Comparator	Participants will receive insulin glargine	Drug: insulin glargine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of treatment-emergent hypoglycaemic episodes	Number of 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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Neuss		41460	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://novonordisk-trials.com

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069036	Insulin Glargine

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided