Diabetes Mellitus, Type 1NCT03987802
An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 36 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Faster-acting insulin aspart
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 36 sitesIndia
- Study dates
- 20 Jan 2021to 28 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
India36 sites
Vijayratna Diagnostic & Scientific Obesity Clinic
Ahmedabad, Gujarat, 380007
Life Care Hospital and Research Centre
Bangalore, Karnataka, 560092
Pranav Diabetes Centre
Bangalore
Karnataka Institute of Endocrinology & Research
Bengaluru, Karnataka, 560069
Malabar Institute of Medical Sciences Ltd,
Calicut, Kerala, 673016
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, 160012
Kg Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, 641018
Max Super Speciality Hospital, Ghaziabad
Ghaziabad, Uttar Pradesh, 201012
CARE Hospitals
Hyderabad, Andhra Pradesh, 500001
Gandhi Hospital & Medical college
Hyderabad, Telangana, 500003
Osmania General Hospital
Hyderabad, Telangana, 500012
Apollo Hospital Jubilee Hills, Hyderabad
Hyderabad, Telangana, 500033
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan
Regency Hospital
Kanpur, Uttar Pradesh, 208006
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Khurda, Odisha, 751019
Aster Medcity
Kochi, Kerala, 682027
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008
AMRI Hospitals, Dhakuria
Kolkata, West Bengal, 700029
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054
Calcutta Medical College
Kolkata, West Bengal, 700073
Medanta Lucknow Hospital
Lucknow, Uttar Pradesh, 226030
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, 625 020
Max Super Speciality Hospital, Mohali
Mohali, Punjab, 160055
Zandra Healthcare Pvt Ltd
Mumbai, Maharashtra, 400058
Apollo Hospital, Navi Mumbai
Mumbai, Maharashtra, 400614
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, 110017
Dr B L Kapur Memorial Hospital
New Delhi, 110055
Sir Ganga Ram Hospital-Cardiology
New Delhi, 110060
chelleram Diabetes Institute
Pune, Maharashtra, 411021
Siddhi Hospital And Laparoscopy Center Pvt Ltd
Pune, Maharashtra, 411043
PGIMS Rohtak
Rohtak, Haryana, 124001
Unique Hospital
Surat, Gujarat, 395002
Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032
Kerala Institute of Medical Sciences
Trivandrum, Kerala, 695029
About this study
Official title: An Indian Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Fiasp® to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
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.
- Being tested
- Faster-acting insulin aspart
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster-acting insulin aspartDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fiasp® | Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India. Receives: Drug: Faster-acting insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of events
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Secondary outcomes (7)
Serious Adverse Events (SAEs)
Number of events
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Adverse Drug Reactions (ADRs)
Number of events
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Serious Adverse Drug Reactions (SADRs)
Number of events
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported severe hypoglycaemia
Episodes/person-year
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia
Episodes/person-year
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia
Episodes/person-year
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Change in HbA1c
Percent point (%)
Measured: From start of treatment (Week 0) to End of Study Visit (Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start20 Jan 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987802
- Sponsor's protocol ID
- NN1218-4489
- Other IDs
- U1111-1222-9492
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2019
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Indian Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Fiasp® to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03987802
- Acronym / sponsor ID
- NN1218-4489
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiasp® | – | Drug: Faster-acting insulin aspartAdult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faster-acting insulin aspartFaster-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. | Drug | Fiasp® |
Primary outcome
Adverse Events (AEs)
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
7 secondary outcomes
Serious Adverse Events (SAEs)
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Adverse Drug Reactions (ADRs)
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Serious Adverse Drug Reactions (SADRs)
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported severe hypoglycaemia
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Change in HbA1c
Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 36 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.