DM2Phase 3NCT03051243
Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department
A Phase 3 study testing Linagliptin and Basal Insulin and Basal Insulin and Bolus Insulin in people with DM2, run by Rabin Medical Center.
Trial summary
Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85 years old with known with history of DM for more than 3 months and an average of two consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral antidiabetic and insulin on admission) will be enrolled… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- DM2
- What is being tested?
- Linagliptin and Basal Insulin and Basal Insulin and Bolus Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Nov 2019
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male \& female patient with Known history of DM for more than 3 months before randomization.
- Hospital admission due to blood glucose levels ranging between 180-400 mg/dl.
- Average of two consecutive blood glucose levels above 180 mg/dl.
- Age between 18 and 85 years old.
- Home treatment with diet alone, any combination of oral antidiabetic agents, or insulin therapy at daily dose <0.4 units/kg.
Who cannot join
- BG >400 mg/dl in the period before randomization.
- Prior history of hyperglycemic crises.
- Have hyperglycemia without history of diabetes.
- Patient who expected ICU admission or cardiac surgery.
- A history of pancreatitis, active gallbladder disease, Corticosteroid therapy or hepatic disease.
- Impaired renal function (glomerular filtration rate [GFR] <30 mL/min or serum creatinine ≥3.0 mg/dL).
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- History of diabetic ketoacidosis.
- Pregnancy.
- Inability to give informed consent (poor mental status).
About this study
Official title: Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus
Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85 years old with known with history of DM for more than 3 months and an average of two consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1 ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once daily and glulisine (Apidra; sanifi) before meals.
Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.
Read the detailed description
patient in the linagliptin plus basal insulin will receive linagliptin at single dose of 5 mg/day, and a starting total daily dose (TDD) of glargine of 0.3 units/kg/day, while patients >70 years of age and/or with a serum creatinine >2.0 mg/dL will receive starting TDD of 0.15 units/kg.
Patient in the basal bolus group will start at a TDD of 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. In patients >70 years of age and/or with a serum creatinine >2.0 mg/dL, the starting TDD will be reduce to 0.3 units/kg.
The results of BG values will be measured as 2 hour pre meal glucose, bedtime glucose, and mean daily BG after first day at hospital, HbA1c will be measured on the first day of hospitalization.
Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.
Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.
Patients will be instructed to measure and record BG levels (pre meal glucose, bedtime glucose, and mean daily BG) during three days before follow-ups visits.
- Conditions
- DM2
- Being tested
- Linagliptin and Basal Insulin, Basal Insulin and Bolus Insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin and Basal InsulinDrug
Also called Trajenta (Linagliptin)
Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals
Basal Insulin and Bolus InsulinDrug
Also called glargine, glulisine
Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin and Basal Insulin | Active comparator | linagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time. Receives: Drug: Linagliptin and Basal Insulin |
| Basal Insulin and Bolus Insulin | Active comparator | Basal Insulin (Glargine Lantus; Sanofi) based therapy once daily before bedtime and glulisine (Apidra; sanofi) before meals. insulin dose will be 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. Receives: Drug: Basal Insulin and Bolus Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient with mean blood glucose levels
between 80-180 mg/dl.
Measured: After firts day from admission and Up to 14 days, 3 and 6 month after discharge.
Secondary outcomes (4)
Difference in BG values within range
140-180 mg/dl.
Measured: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of hypoglycemic events (BG <70 and or < 40 mg/dL).
<70 and or < 40 mg/dL
Measured: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of episodes of hyperglycemia
>240 mg/dL
Measured: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
TTD (total daily dose) of insulin
units of insulin
Measured: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DM2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Dicker, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051243
- Sponsor's protocol ID
- 0643-14RMC
- Status last verified
- Sep 2017
- First submitted
- 15 Jan 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03051243
- Acronym / sponsor ID
- 0643-14RMC
- Conditions
- DM2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 13 Feb 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.
Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85 years old with known with history of DM for more than 3 months and an average of two consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1 ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once daily and glulisine (Apidra; sanifi) before meals.
Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.
Detailed description
patient in the linagliptin plus basal insulin will receive linagliptin at single dose of 5 mg/day, and a starting total daily dose (TDD) of glargine of 0.3 units/kg/day, while patients >70 years of age and/or with a serum creatinine >2.0 mg/dL will receive starting TDD of 0.15 units/kg.
Patient in the basal bolus group will start at a TDD of 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. In patients >70 years of age and/or with a serum creatinine >2.0 mg/dL, the starting TDD will be reduce to 0.3 units/kg.
The results of BG values will be measured as 2 hour pre meal glucose, bedtime glucose, and mean daily BG after first day at hospital, HbA1c will be measured on the first day of hospitalization.
Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.
Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.
Patients will be instructed to measure and record BG levels (pre meal glucose, bedtime glucose, and mean daily BG) during three days before follow-ups visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin and Basal Insulin | Active comparator | Drug: Linagliptin and Basal Insulinlinagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time. |
| Basal Insulin and Bolus Insulin | Active comparator | Drug: Basal Insulin and Bolus InsulinBasal Insulin (Glargine Lantus; Sanofi) based therapy once daily before bedtime and glulisine (Apidra; sanofi) before meals. insulin dose will be 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male \& female patient with Known history of DM for more than 3 months before randomization.
- Hospital admission due to blood glucose levels ranging between 180-400 mg/dl.
- Average of two consecutive blood glucose levels above 180 mg/dl.
- Age between 18 and 85 years old.
- Home treatment with diet alone, any combination of oral antidiabetic agents, or insulin therapy at daily dose <0.4 units/kg.
Key exclusion criteria (9 listed)
- BG >400 mg/dl in the period before randomization.
- Prior history of hyperglycemic crises.
- Have hyperglycemia without history of diabetes.
- Patient who expected ICU admission or cardiac surgery.
- A history of pancreatitis, active gallbladder disease, Corticosteroid therapy or hepatic 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 |
|---|---|---|
| Linagliptin and Basal InsulinAlso: Trajenta (Linagliptin)Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals | Drug | Linagliptin and Basal Insulin |
| Basal Insulin and Bolus InsulinAlso: glargine, glulisineBasal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals | Drug | Basal Insulin and Bolus Insulin |
Primary outcome
Percentage of patient with mean blood glucose levels
Time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge.
between 80-180 mg/dl.
4 secondary outcomes
Difference in BG values within range
Time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of hypoglycemic events (BG <70 and or < 40 mg/dL).
Time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of episodes of hyperglycemia
Time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
TTD (total daily dose) of insulin
Time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linagliptin and Basal Insulin and Basal Insulin and Bolus Insulin in people with DM2, run by Rabin Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Percentage of patient with mean blood glucose levels (time frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge.). 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 11 Sep 2017.