An Indian Post Marketing Study of Mealtime Insulin, Fiasp... | NCT03987802

ID	Type	Description	Link
U1111-1222-9492	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Apr 2026

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

Jan 20, 2021Actual

Primary Completion Date

Jun 28, 2022Actual

Completion Date

Jun 28, 2022Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 13, 2019

First Posted Date

Jun 17, 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

Apr 3, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

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 is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their doctors. Participants will administer Fiasp® as prescribed by their doctors. The study will last for about 6 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fiasp®		Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.	Drug: Faster-acting insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Faster-acting insulin aspart	Drug	Faster-acting insulin aspart given as subcutaneous (s.c., under the skin) injections according to routine clinical practice. The decision to initiate treatment with commercially available Fiasp® must be made by the patient and the treating physician before and independently from the decision to include the patient in this study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs)	Number of events	From start of treatment (Week 0) to End of Study Visit (Week 26)

Secondary Outcomes

Measure	Description	Time Frame
Serious Adverse Events (SAEs)	Number of events	From start of treatment (Week 0) to End of Study Visit (Week 26)
Adverse Drug Reactions (ADRs)	Number of events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female, age equal to or above 18 years at the time of signing the informed consent.
Patients diagnosed with diabetes mellitus.
Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.

Exclusion Criteria:

Known or suspected hypersensitivity to study product(s) or related products.
Patients on or likely to use insulin pump therapy during the study period
Previous participation in this study. Participation is defined as having given signed informed consent.
Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation.
Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start.
Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CARE Hospitals		Hyderabad	Andhra Pradesh	500001	India
Vijayratna Diagnostic & Scientific Obesity Clinic

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

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases