Type 2 Diabetes MellitusNCT03406663
The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
A study testing Group 1 and Group 2 in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2017to 14 Jul 2020
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 19 years
- Treated for T2D for at least 6 months
- Uncontrolled T2D
- Use of SMPG
- HbA1c > 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c > 7% and ≤ 11% in insulin naive patients
- Signed informed consent
Who cannot join
- Type 1 diabetes mellitus
- Pregnancy or lactation
- Night-shift worker
- Unwilling to inject insulin or perform SMPG
- Treated with insulin other than basal insulin within the previous 3 months
- Not on stable dose of basal insulin (±20%) in the last 3 months
Show all 14Show fewer
- Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months
- History of alcohol or drug abuse
- Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study
- Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study
- Known drug allergy to insulin
- Not signed informed consent
- Incompletion of the study
- Participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Korean, Single-center, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Patients With Type 2 Diabetes Mellitus
The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.
Read the detailed description
The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.
In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Group 1, Group 2
- Keywords
- Insulin
- 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.
Group 1Behavioural
Also called INSIGHT algorithm
Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents.
Fasting SMPG in the range of
≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, < 4.4 mmol/L, reduce 1 unit of Gla-300 dose
Group 2Behavioural
Also called EDITION algorithm
Fasting SMPG (median of the last 3 days including current day) in the range of
- 7.8 mmol/L, increase 6 units of Gla-300 dose, > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change,
- 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose, < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm).
Titration algorithms:
Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents.
Fasting SMPG in the range of
1. ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose
2. > 4.4 and ≤ 5.6 mmol/L, no change
3. < 4.4 mmol/L, reduce 1 unit of Gla-300 dose Receives: Behavioral: Group 1 |
| Group 2 | Active comparator | In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm).
Fasting SMPG (median of the last 3 days including current day) in the range of
1. ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose
2. > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose
3. > 4.4 and ≤ 5.6 mmol/L, no change
4. ≥ 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose
5. < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator Receives: Behavioral: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
Measured: up to 12 weeks
Secondary outcomes (11)
Changes in HbA1c (%)
Measured: up to 12 weeks
Fasting plasma glucose (mmol/L)
Measured: up to 12 weeks
Fasting SMPG (mmol/L)
Measured: up to 12 weeks
7-point SMPG (mmol/L)
Measured: up to 12 weeks
Proportion of patients at HbA1c ≤ 7%
Measured: up to 12 weeks
Change in insulin dose (IU)
Measured: up to 12 weeks
Change in body weight (kilogram)
Measured: up to 12 weeks
Hypoglycemia (number of patients)
Measured: up to 12 weeks
Adverse events
Measured: up to 12 weeks
Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
Measured: up to 12 weeks
Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Oct 2017
- Primary completion17 Jan 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Young Min Cho, Seoul National University Hospital
- Investigators
- Young Min Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406663
- Sponsor's protocol ID
- H-1708-078-878
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bae JH, Ahn CH, Yang YS, Moon SJ, Kwak SH, Jung HS, Park KS, Cho YM. Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial. Diabetes Metab J. 2022 Jan;46(1):71-80. doi: 10.4093/dmj.2020.0274. Epub 2021 Jun 16.
PubMed 34130445
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Korean, Single-center, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03406663
- Acronym / sponsor ID
- H-1708-078-878
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 23 Jan 2018 (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.
The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.
Detailed description
The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.
In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Group 1In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm). Titration algorithms: Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of 1. ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose 2. > 4.4 and ≤ 5.6 mmol/L, no change 3. < 4.4 mmol/L, reduce 1 unit of Gla-300 dose |
| Group 2 | Active comparator | Behavioral: Group 2In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm). Fasting SMPG (median of the last 3 days including current day) in the range of 1. ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose 2. > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose 3. > 4.4 and ≤ 5.6 mmol/L, no change 4. ≥ 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose 5. < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 19 years
- Treated for T2D for at least 6 months
- Uncontrolled T2D
- Use of SMPG
- HbA1c > 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c > 7% and ≤ 11% in insulin naive patients
Key exclusion criteria (14 listed)
- Type 1 diabetes mellitus
- Pregnancy or lactation
- Night-shift worker
- Unwilling to inject insulin or perform SMPG
- Treated with insulin other than basal insulin within the previous 3 months
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 |
|---|---|---|
| Group 1Also: INSIGHT algorithmPatients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, < 4.4 mmol/L, reduce 1 unit of Gla-300 dose | Behavioural | Group 1 |
| Group 2Also: EDITION algorithmFasting SMPG (median of the last 3 days including current day) in the range of * 7.8 mmol/L, increase 6 units of Gla-300 dose, > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, * 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose, < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator | Behavioural | Group 2 |
Primary outcome
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
Time frame: up to 12 weeks
11 secondary outcomes
Changes in HbA1c (%)
Time frame: up to 12 weeks
Fasting plasma glucose (mmol/L)
Time frame: up to 12 weeks
Fasting SMPG (mmol/L)
Time frame: up to 12 weeks
7-point SMPG (mmol/L)
Time frame: up to 12 weeks
Proportion of patients at HbA1c ≤ 7%
Time frame: up to 12 weeks
Change in insulin dose (IU)
Time frame: up to 12 weeks
Change in body weight (kilogram)
Time frame: up to 12 weeks
Hypoglycemia (number of patients)
Time frame: up to 12 weeks
Adverse events
Time frame: up to 12 weeks
Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
Time frame: up to 12 weeks
Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)
Time frame: up to 12 weeks
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 22 Oct 2020.
- Derived from this study: PubMed 34130445Bae JH, Ahn CH, Yang YS, Moon SJ, Kwak SH, Jung HS, Park KS, Cho YM. Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial. Diabetes Metab J. 2022 Jan;46(1):71-80. doi: 10.4093/dmj.2020.0274. Epub 2021 Jun 16.
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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.
Young Min Cho, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 and Group 2 in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 14 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 22 Oct 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 South Korea. 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?
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks (time frame: up to 12 weeks). 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 NCT03406663, 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 22 Oct 2020.