Type2 DiabetesPhase 4NCT03349840
Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
A Phase 4 study testing Insulin Degludec U100 and Insulin Glargine in people with Type2 Diabetes, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
Trial summary
This is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Insulin Degludec U100 and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteQatar
- Study dates
- 7 Jan 2018to 31 Dec 2018
- Phase
- Phase 4
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Patients must be on any basal insulin (once daily)
- Patients must be on any basal insulin (twice daily)
- Patients on stable dose of oral antidiabetes drugs can be included (No change in the dose for the previous 12 weeks)
- Body Mass Index <40kg/m2
- Subjects who have signed informed consent form
- Patients will be fasting during Ramadan
Who cannot join
- Type 1 diabetes
- Type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin
- On GLP-1 receptor agonists medication
- On glinide medication
- Ischaemic heart disease
- Left bundle branch block on ECG
Show all 9Show fewer
- Active diabetic retinopathy or maculopathy requiring acute treatment
- Unwilling to follow the protocol
- Pregnancy, intention to become pregnant, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved.
Read the detailed description
This will be an open label randomised prospective study that will involve 280 insulin-treated patients with type 2 diabetes and who are receiving a basal insulin as part of their treatment regimen. The power calculation suggests a subject number of 250 but to account for a 10% drop out then 280 patients will be recruited competitively. To account for an estimated 30% screen failure then 400 patients will have to be screened. Of those eligible140 patients will be randomized to insulin glargine U100 and 140 patients randomised to insulin degludec: patients will be stabilised on that regimen so that the primary objective of the study to compare glycemic control for those on insulin glargine U100 compared to those on insulin degludec can be undertaken.
Insulin glargine U100 and insulin degludec will be given once daily in the evening before Ramadan, 10-20 weeks prior to the onset of Ramadan as a run in period for stabilisation, and to be given at Iftar (breaking of the fast) in the evening of Ramadan. In accord with the latest International Diabetes Federation (IDF) guidelines the dose of both the glargine U100 and insulin degludec will be reduced by 15% during Ramadan http://www.idf.org/sites/default/files/IDF-Diabetes and Ramadan (DAR)-Practical-Guidelines-Final-Low.pdf), After Ramadan basal insulin will be increased to that of the pre-Ramadan dose. In accord with the insulin degludec label guidelines (and those of insulin glargine U100), a one to one dose will be implemented if switching from a single basal injection; however, a dose reduction of 20% will be implemented if having to switch from a twice daily basal injection (including those on twice daily insulin glargine U100 randomised to once daily insulin glargine U100). Thus, for those subjects already on once daily insulin glargine U100 and randomised to insulin glargine U100 then no dose reduction will be undertaken, nor will a dose reduction be undertaken for those subjects on once daily insulin glargine U100 and randomised to insulin degludec.
Oral hypoglycemic agents will be on a stable dose that has not been altered in the preceding 12 weeks and will be continued unchanged through the study period
During the 10-20 week run in period to Ramadan fasting blood glucose will be titrated to less than 5mmol/l (90 mg/dl)and insulin dose will be increased or decreased according to the average of three previous fasting blood glucose measurements from the previous week (weekly titration). During Ramadan fasting blood glucose will be measured before Iftar (breaking of the fast) and will aim for a fasting blood glucose of 5mmol/l (90 mg/dl).
Glycosylated hemoglobine (HbA1c) measurement will be done at baseline and 2-4 weeks before Ramadan; two weeks after Ramadan and at the end of the 8 weeks study period following Ramadan
Insulin dose will be increased by 2 units for FBG 7.1-7.9 mmol/L (120-140 mg/dl), 4 units 8.0-8.9 mmol/L (141-160 mg/dl), and 6 units 9.0 mmol/L (more than 160 mg/dl) and above. Insulin dose will be decreased by 2 units for FBG 3.1-3.9 mmol/dl (55-70 mg/dl), decreased 4 units FBG <3.1 mmol/L. During Ramadan fasting blood will be measured before Iftar. Titration of insulin will be continued for the 8 weeks following Ramadan
Patients will be contacted by a diabetes educator every 2 weeks by telephone to gather the details of their glycemic control that will be discussed with the medical investigators to alter their insulin dose and to report any hypoglycaemic events - all patients will be encouraged to measure their blood glucose if a hypoglycaemic event occurs
At the end of the study patients will have the option to be converted back to their previous basal insulin before the study. However, should they wish to continue on insulin glargine U100/ then this will be available to be continued per local guidelines.
Study Visit Schedule
Visit 1 (Initial visit: 10 to 20 weeks before Ramadan) and will include:
- Consent, inclusion and exclusion criteria, Medical history
- Anthropometric measurement - Height, Weight, Waist circumference, blood pressure.
- Blood collection for CBC, routine biochemistry including creatinine (and calculated eGFR), HbA1c, full blood count (FBC), alanine aminotransferase (ALT), sodium (NA), potassiumK (25ml)
- Electrocardiograph (ECG).
Visit 2 (within 2 weeks of visit 1: 8-18 weeks before Ramadan) and will include:
- Randomisation, randomization sequence will be created by a statistician before the start of the recruitment
- Fasting plasma glucose
- Education session and instruction on the use of the insulin degludec / glargine U100 pen. Following successful education then patients will go to pharmacy to pick up their insulin degludec/glargine U100.
- Dietary education session to optimize the effect of the change to degludec/glargine U100
- Distribution of Blood glucose meters and Diaries for the patients to record the value of their blood glucose through the period of the study.
Visit 3 (telephone calls):
Telephone calls will be conducted by the assigned clinical research coordinators (CRCs) for each subject with an interval of two weeks in which the subject will be asked about their health and readings of their blood glucose levels, they will also be asked if they had any episode of hypoglycaemia or any adverse events.
Visit 4. Just prior to Ramadan:
This is likely to be within 1-2 weeks (14 day window) before Ramadan to logistically get all patients in for that blood test.
Fasting blood will be collected for glucose, FBC, Na , K , creatinine (estimated glomerular filtration rate -eGFR), ALT and HbA1c (25ml).
Visit 5 (telephone calls):
Telephone calls will be conducted by the assigned CRCs for each subject with an interval of two weeks into Ramdan in which the subject will be asked about their health, readings of their blood glucose levels, and they will also be asked if they had any episode of hypoglycaemia or any adverse events.
Visit 6 (two weeks after Ramadan) and will include:
Fasting blood collection for glucose, FBC, HbA1c , NA , K and creatinine (eGFR estimation), ALT (25ml).
This is likely to be within 1-2 weeks (14 day window) after Ramadan to logistically get all patients in for that blood test (6 weeks between HbA1c measurements).
Visit 7 (4 weeks after visit 6 (to be done over a 14 day period) and this will include:
End of study visit and determination if patient wants to continue with insulin degludec/glargine U100 or to convert back to the basal insulin that they were on before the study
- Conditions
- Type2 Diabetes
- Being tested
- Insulin Degludec U100, Insulin Glargine
- Keywords
- type 2 diabetes, insulin, glargine u100, degludec, Ramadan
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Degludec U100Drug
Also called tresiba
Patients on any basal insulin including insulin glargine will be randomised and converted to basal degludec insulin
Insulin GlargineDrug
Also called lantis
Patients on any basal insulin including insulin glargine will be randomised and either glargine will be continued or will beconverted to basal glargine insulin
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine U100 | Active comparator | Intervention: half of the subjects will be randomised to insulin glargine U100 basal insulin treatment (or continued on glargine if already treated) that will be administered daily in the evening Receives: Drug: Insulin Glargine |
| insulin degludec U100 | Active comparator | Intervention: half of the subjects will be randomised to insulin degludec U100 basal insulin treatment that will be administered daily in the evening Receives: Drug: Insulin Degludec U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
To measure HbA1c at the end of Ramadan between arms.
Measured: 6 weeks
Secondary outcomes (4)
Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
To measure fasting glucose at the end of Ramadan between arms.
Measured: 6 weeks
Hypoglycemia between arms
To measure the number hypoglycemia between arms to the end of Ramadan
Measured: 6 weeks
HbA1c end point achieved
To measure the number of subjects who achieve a HbA1c <7.5% at the end of Ramadan between treatment arms
Measured: 6 weeks
Incidence of Treatment-Emergent Adverse Events
To measure the number of adverse events between the 2 treatment arms before and after Ramadan
Measured: 14-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start7 Jan 2018
- Primary completion3 Aug 2018
- Study completion31 Dec 2018
Why it stopped: The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomised prospective study
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Cornell Medical College in Qatar
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Stephen Atkin, MD, Principal investigator, Weill Cornell Medicine Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349840
- Sponsor's protocol ID
- U1111-1192-2978
- Status last verified
- Jun 2020
- First submitted
- 2 Nov 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
- ClinicalTrials.gov ID
- NCT03349840
- Acronym / sponsor ID
- U1111-1192-2978
- Conditions
- Type2 Diabetes
- Keywords
- type 2 diabetes, insulin, glargine u100, degludec, Ramadan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Weill Cornell Medical College in QatarUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Nov 2017 (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 is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved.
Detailed description
This will be an open label randomised prospective study that will involve 280 insulin-treated patients with type 2 diabetes and who are receiving a basal insulin as part of their treatment regimen. The power calculation suggests a subject number of 250 but to account for a 10% drop out then 280 patients will be recruited competitively. To account for an estimated 30% screen failure then 400 patients will have to be screened. Of those eligible140 patients will be randomized to insulin glargine U100 and 140 patients randomised to insulin degludec: patients will be stabilised on that regimen so that the primary objective of the study to compare glycemic control for those on insulin glargine U100 compared to those on insulin degludec can be undertaken.
Insulin glargine U100 and insulin degludec will be given once daily in the evening before Ramadan, 10-20 weeks prior to the onset of Ramadan as a run in period for stabilisation, and to be given at Iftar (breaking of the fast) in the evening of Ramadan. In accord with the latest International Diabetes Federation (IDF) guidelines the dose of both the glargine U100 and insulin degludec will be reduced by 15% during Ramadan http://www.idf.org/sites/default/files/IDF-Diabetes and Ramadan (DAR)-Practical-Guidelines-Final-Low.pdf), After Ramadan basal insulin will be increased to that of the pre-Ramadan dose. In accord with the insulin degludec label guidelines (and those of insulin glargine U100), a one to one dose will be implemented if switching from a single basal injection; however, a dose reduction of 20% will be implemented if having to switch from a twice daily basal injection (including those on twice daily insulin glargine U100 randomised to once daily insulin glargine U100). Thus, for those subjects already on once daily insulin glargine U100 and randomised to insulin glargine U100 then no dose reduction will be undertaken, nor will a dose reduction be undertaken for those subjects on once daily insulin glargine U100 and randomised to insulin degludec.
Oral hypoglycemic agents will be on a stable dose that has not been altered in the preceding 12 weeks and will be continued unchanged through the study period
During the 10-20 week run in period to Ramadan fasting blood glucose will be titrated to less than 5mmol/l (90 mg/dl)and insulin dose will be increased or decreased according to the average of three previous fasting blood glucose measurements from the previous week (weekly titration). During Ramadan fasting blood glucose will be measured before Iftar (breaking of the fast) and will aim for a fasting blood glucose of 5mmol/l (90 mg/dl).
Glycosylated hemoglobine (HbA1c) measurement will be done at baseline and 2-4 weeks before Ramadan; two weeks after Ramadan and at the end of the 8 weeks study period following Ramadan
Insulin dose will be increased by 2 units for FBG 7.1-7.9 mmol/L (120-140 mg/dl), 4 units 8.0-8.9 mmol/L (141-160 mg/dl), and 6 units 9.0 mmol/L (more than 160 mg/dl) and above. Insulin dose will be decreased by 2 units for FBG 3.1-3.9 mmol/dl (55-70 mg/dl), decreased 4 units FBG <3.1 mmol/L. During Ramadan fasting blood will be measured before Iftar. Titration of insulin will be continued for the 8 weeks following Ramadan
Patients will be contacted by a diabetes educator every 2 weeks by telephone to gather the details of their glycemic control that will be discussed with the medical investigators to alter their insulin dose and to report any hypoglycaemic events - all patients will be encouraged to measure their blood glucose if a hypoglycaemic event occurs
At the end of the study patients will have the option to be converted back to their previous basal insulin before the study. However, should they wish to continue on insulin glargine U100/ then this will be available to be continued per local guidelines.
Study Visit Schedule
Visit 1 (Initial visit: 10 to 20 weeks before Ramadan) and will include:
- Consent, inclusion and exclusion criteria, Medical history
- Anthropometric measurement - Height, Weight, Waist circumference, blood pressure.
- Blood collection for CBC, routine biochemistry including creatinine (and calculated eGFR), HbA1c, full blood count (FBC), alanine aminotransferase (ALT), sodium (NA), potassiumK (25ml)
- Electrocardiograph (ECG).
Visit 2 (within 2 weeks of visit 1: 8-18 weeks before Ramadan) and will include:
- Randomisation, randomization sequence will be created by a statistician before the start of the recruitment
- Fasting plasma glucose
- Education session and instruction on the use of the insulin degludec / glargine U100 pen. Following successful education then patients will go to pharmacy to pick up their insulin degludec/glargine U100.
- Dietary education session to optimize the effect of the change to degludec/glargine U100
- Distribution of Blood glucose meters and Diaries for the patients to record the value of their blood glucose through the period of the study.
Visit 3 (telephone calls):
Telephone calls will be conducted by the assigned clinical research coordinators (CRCs) for each subject with an interval of two weeks in which the subject will be asked about their health and readings of their blood glucose levels, they will also be asked if they had any episode of hypoglycaemia or any adverse events.
Visit 4. Just prior to Ramadan:
This is likely to be within 1-2 weeks (14 day window) before Ramadan to logistically get all patients in for that blood test.
Fasting blood will be collected for glucose, FBC, Na , K , creatinine (estimated glomerular filtration rate -eGFR), ALT and HbA1c (25ml).
Visit 5 (telephone calls):
Telephone calls will be conducted by the assigned CRCs for each subject with an interval of two weeks into Ramdan in which the subject will be asked about their health, readings of their blood glucose levels, and they will also be asked if they had any episode of hypoglycaemia or any adverse events.
Visit 6 (two weeks after Ramadan) and will include:
Fasting blood collection for glucose, FBC, HbA1c , NA , K and creatinine (eGFR estimation), ALT (25ml).
This is likely to be within 1-2 weeks (14 day window) after Ramadan to logistically get all patients in for that blood test (6 weeks between HbA1c measurements).
Visit 7 (4 weeks after visit 6 (to be done over a 14 day period) and this will include:
End of study visit and determination if patient wants to continue with insulin degludec/glargine U100 or to convert back to the basal insulin that they were on before the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomised prospective study
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine U100 | Active comparator | Drug: Insulin GlargineIntervention: half of the subjects will be randomised to insulin glargine U100 basal insulin treatment (or continued on glargine if already treated) that will be administered daily in the evening |
| insulin degludec U100 | Active comparator | Drug: Insulin Degludec U100Intervention: half of the subjects will be randomised to insulin degludec U100 basal insulin treatment that will be administered daily in the evening |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
- Patients must be on any basal insulin (once daily)
- Patients must be on any basal insulin (twice daily)
- Patients on stable dose of oral antidiabetes drugs can be included (No change in the dose for the previous 12 weeks)
Key exclusion criteria (9 listed)
- Type 1 diabetes
- Type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin
- On GLP-1 receptor agonists medication
- On glinide medication
- Ischaemic heart disease
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 Degludec U100Also: tresibaPatients on any basal insulin including insulin glargine will be randomised and converted to basal degludec insulin | Drug | insulin degludec U100 |
| Insulin GlargineAlso: lantisPatients on any basal insulin including insulin glargine will be randomised and either glargine will be continued or will beconverted to basal glargine insulin | Drug | Insulin glargine U100 |
Primary outcome
Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
Time frame: 6 weeks
To measure HbA1c at the end of Ramadan between arms.
4 secondary outcomes
Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.
Time frame: 6 weeks
Hypoglycemia between arms
Time frame: 6 weeks
HbA1c end point achieved
Time frame: 6 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 14-24 weeks
Results and safety
The study was stopped early (reason given: The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data
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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.
Stephen Atkin, MD principal investigator
Weill Cornell Medicine Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec U100 and Insulin Glargine in people with Type2 Diabetes, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
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 9 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: stopped early, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits). Results are not available in the source record.
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?
Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan. (time frame: 6 weeks). 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 Jun 2020.