Diabetes Mellitus, Type 2Phase 2NCT03922750
A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
A Phase 2 study testing Insulin icodec and Insulin glargine U100 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 38 sites in 5 countries.
Trial summary
This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin icodec and Insulin glargine U100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 9 May 2019to 27 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
- Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
- Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
- Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records).
- Free or fixed combination therapy: Metformin as outlined above with or without dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose.
- Body mass index (BMI) less than or equal to 40.0 kg/m^2.
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
- Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
- Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States13 sites
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Dallas, Texas, 75226
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Canada10 sites
Novo Nordisk Investigational Site
Brampton, Ontario, L6S 0C6
Novo Nordisk Investigational Site
Concord, Ontario, L4K 4M2
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2E1
Novo Nordisk Investigational Site
Etobicoke, Ontario, M9R 4E1
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Markham, Ontario, L3P 7P2
Novo Nordisk Investigational Site
Sarnia, Ontario, N7T 4X3
Novo Nordisk Investigational Site
Surrey, British Columbia, V3Z 2N6
Novo Nordisk Investigational Site
Vancouver, British Columbia, V5Y 3W2
Germany6 sites
Novo Nordisk Investigational Site
Falkensee, 14612
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Oldenburg I. Holst, 23758
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
Italy5 sites
Novo Nordisk Investigational Site
Bergamo, 24127
Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Milan, 20122
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Roma, 00161
Czechia4 sites
Novo Nordisk Investigational Site
Broumov, 550 01
Novo Nordisk Investigational Site
Holešov, 76901
Novo Nordisk Investigational Site
Hranice, 75301
Novo Nordisk Investigational Site
Trutnov, 541 01
About this study
Official title: A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus
This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin icodec, Insulin glargine U100
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin icodecDrug
Also called Insulin 287
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
Insulin glargine U100Drug
Participants will receive s.c. injections of insulin glargine OD for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Insulin 287 (with 100% loading dose) | Experimental | Participants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used. Receives: Drug: Insulin icodec |
| Insulin 287 (without loading dose) | Experimental | Participants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used. Receives: Drug: Insulin icodec |
| Insulin glargine U100 | Active comparator | Participants will receive insulin glargine U100 once daily (OD). Receives: Drug: Insulin glargine U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Measured: During the last 2 weeks of treatment (week 15 and 16)
Secondary outcomes (8)
Change in Glycosylated Haemoglobin (HbA1c)
Estimated mean change from baseline (week 0) in HbA1c at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Measured: From baseline week 0 (V2) to week 16 (V18)
Change in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline (week 0) in FPG at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Measured: From baseline week 0 (V2) to week 16 (V18)
Change in Body Weight
Estimated mean change from baseline (week 0) in body weight at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Measured: From baseline week 0 (V2) to week 16 (V18)
Weekly Insulin Dose
Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Measured: During the last 2 weeks of treatment (week 15 and 16)
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event(AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage.. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product until the follow-up visit or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin. Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.
Measured: From baseline week 0 (V2) to week 21 (V20)
Number of Severe Hypoglycaemic Episodes (Level 3)
Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred during weeks 0-16 are presented.
Measured: From baseline week 0 (V2) to week 16 (V18)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of <3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG)meter or severe hypoglycaemic episodes (level 3) that occured during weeks 0-16 are presented.
Measured: From baseline week 0 (V2) to week 16 (V18)
Number of Hypoglycaemic Alert Episodes(Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by BG Meter)
Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter) that occured during weeks 0-16 are presented.
Measured: From baseline week 0 (V2) to week 16 (V18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start9 May 2019
- Primary completion19 Dec 2019
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 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
- NCT03922750
- Sponsor's protocol ID
- NN1436-4466
- Other IDs
- U1111-1219-5541, 2018-003407-18, 2018
- Status last verified
- Jan 2022
- First submitted
- 17 Apr 2019
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Bajaj HS, Bergenstal RM, Christoffersen A, Davies MJ, Gowda A, Isendahl J, Lingvay I, Senior PA, Silver RJ, Trevisan R, Rosenstock J. Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial. Diabetes Care. 2021 Jul;44(7):1586-1594. doi: 10.2337/dc20-2877. Epub 2021 Apr 19.
PubMed 33875485
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03922750
- Acronym / sponsor ID
- NN1436-4466
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin 287 (with 100% loading dose) | Experimental | Drug: Insulin icodecParticipants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used. |
| Insulin 287 (without loading dose) | Experimental | Drug: Insulin icodecParticipants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used. |
| Insulin glargine U100 | Active comparator | Drug: Insulin glargine U100Participants will receive insulin glargine U100 once daily (OD). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
- Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
- Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
Key exclusion criteria (8 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
- Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
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 |
|---|---|---|
| Insulin icodecAlso: Insulin 287Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks. | Drug | Insulin 287 (with 100% loading dose), Insulin 287 (without loading dose) |
| Insulin glargine U100Participants will receive s.c. injections of insulin glargine OD for 16 weeks | Drug | Insulin glargine U100 |
Primary outcome
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)
Time frame: During the last 2 weeks of treatment (week 15 and 16)
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
8 secondary outcomes
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: From baseline week 0 (V2) to week 16 (V18)
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline week 0 (V2) to week 16 (V18)
Change in Body Weight
Time frame: From baseline week 0 (V2) to week 16 (V18)
Weekly Insulin Dose
Time frame: During the last 2 weeks of treatment (week 15 and 16)
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline week 0 (V2) to week 21 (V20)
Number of Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline week 0 (V2) to week 16 (V18)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline week 0 (V2) to week 16 (V18)
Number of Hypoglycaemic Alert Episodes(Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by BG Meter)
Time frame: From baseline week 0 (V2) to week 16 (V18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33875485Bajaj HS, Bergenstal RM, Christoffersen A, Davies MJ, Gowda A, Isendahl J, Lingvay I, Senior PA, Silver RJ, Trevisan R, Rosenstock J. Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial. Diabetes Care. 2021 Jul;44(7):1586-1594. doi: 10.2337/dc20-2877. Epub 2021 Apr 19.
- 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
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin icodec and Insulin glargine U100 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 38 sites in 5 countries.
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 8 inclusion and 8 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada, Germany, Italy, Czechia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring) (time frame: During the last 2 weeks of treatment (week 15 and 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922750, which also lists 1 linked publication.
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 18 Jan 2022.