An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Novo Nordisk A/S · Observational
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Among 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S — 25 open to participants now, 29 under way, 11 of them phase 3. Diabetes Mellitus, Type 2 · Novo Nordisk A/S.
Among the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, this one is the 146th largest by enrollment of the 215 observational ones that give a count, is one of 20 that started in 2018, is one of 215 observational ones, and was the 447th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →25 of the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S are open now, in 12 countries. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Germany
Ages 25–69 · Healthy volunteers
Novo Nordisk A/S · Sites in United States
Ages 18+
Novo Nordisk A/S · Sites in United States
Ages 18+
Novo Nordisk A/S · Sites in United States
Ages 18+
Novo Nordisk A/S · Sites in United States, Argentina, Brazil and 13 more countries
Ages 45+
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
643 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 20 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 462 is above the median of 300 across 1,742 observational studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 209 across the 428 interventional studies, 938 across the 215 observational. Of the 603 that completed or were terminated, 174 (29%) have results posted.
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Novo Nordisk A/S is the lead sponsor of 1,408 studies on the registry; 105 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
8 of the studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07817251Phase 3Novo Nordisk A/SResearch Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema | 2027-06-09 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT05689372Novo Nordisk A/SRegulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea | 2026-11-30 |
| NCT07532863Novo Nordisk A/SA Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants | 2027-03-27 |
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Among the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about the health and the diabetes treatment. Participants will complete these during the normally scheduled visits with the study doctor.
Participants with type 2 diabetes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks
Drug: Semaglutide
Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
Change in Glycated Haemoglobin A1c (HbA1c)
Measured in % points
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in HbA1c
Measured in mmol/mol
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in body weight
Measured in kg
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in body weight
Measured in %
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in waist circumference
Measured in cm
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
HbA1c level at end of study: < 8.0% (64 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: \<8.0%
Time frame: At end of study (week 28-38)
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: \<7.5%
Time frame: At end of study (week 28-38)
HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: \<7.0%
Time frame: At end of study (week 28-38)
Reduction in HbA1c of 1.0% point or more (yes/no)
Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Weight reduction of 3.0% or more (yes/no)
Number of participants who achieved/not achieved weight reduction of 3.0% or more
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Weight reduction of 5.0% or more (yes/no)
Number of participants who achieved/not achieved weight reduction of 5.0% or more
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Patient reported severe or documented hypoglycaemia (yes/no)
Number of participants who reported/not reported severe or documented hypogycaemia
Time frame: Between baseline (week 0) and end of study (week 28-38)
Change in Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.
Time frame: Baseline (week 0), end of study (week 28-38)
Change in Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction
The change version (DTSQc) has the same 8 items as the status version, but is reworded to direct the patients to compare the experience of the current treatment with the experience of previous treatment. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.
Time frame: Baseline (week 0), end of study (week 28-38)
Change in Short Form (SF)-36 v2: Physical summary component
The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).
Time frame: Baseline (week 0), end of study (week 28-38)
Change in SF-36 v2: Mental summary component
The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).
Time frame: Baseline (week 0), end of study (week 28-38)
Patient completed the study under treatment with semaglutide (yes/no)
Number of patients who completed/not completed the study under treatment with semaglutide
Time frame: At end of study (week 28-38)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · www.novonordisk-trials.com
Ran from Mar 2018 to primary completion in Dec 2019, 20 months.
Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 20 months is below that.
Counting every sponsor, half of 603 studies reached it within 32 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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