Type 2 DiabetesNCT01281605
Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes
A study testing Active titration algorithm and Usual titration algorithm in people with Type 2 Diabetes, run by Mackay Memorial Hospital at 3 sites in Taiwan.
Trial summary
This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Active titration algorithm and Usual titration algorithm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 3 sitesTaiwan
- Study dates
- Jan 2011to May 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
Who cannot join
- Patients with type 1 diabetes.
- Renal dialysis patients.
- History of hypoglycemia unawareness.
- Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
- Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
- Patients hypersensitive with insulin detemir or its excipients.
- Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
Hsinchu, 30067
Mackay Memorial Hospital
Taipei, 10449
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
Taitung, 95054
About this study
Official title: Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.
Read the detailed description
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.
Inclusion criteria:
Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:
- Active titration algorithm: contact with investigator by telephone weekly.
- Usual titration algorithm: contact with investigator only at routine study visit.
- Conditions
- Type 2 Diabetes
- Being tested
- Active titration algorithm, Usual titration algorithm
- Keywords
- Type 2 diabetes, Basal insulin, Insulin detemir, Insulin titration algorithm
- 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.
Active titration algorithmBehavioural
Also called Insulin detemir active titration algorithm
Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl).
Usual titration algorithmBehavioural
Also called Insulin detemir usual titration algorithm
All patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Active titration algorithm | Active comparator | titrate insulin dose by contacting with investigator by telephone weekly. Receives: Behavioral: Active titration algorithm |
| Usual titration algorithm | Experimental | contact with investigator only at routine study visit. Receives: Behavioral: Usual titration algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the change in HbA1c between two study groups at Week 24.
compare the change in HbA1c between two study groups after 24 weeks treatment.
Measured: 24 weeks
Secondary outcomes (5)
To compare the change in HbA1C between two study groups at Week 12.
compare the change in HbA1C between two study groups after 12 of treatment.
Measured: 12 weeks
To compare the proportion of patients achieving HbA1C <7% at Week 24
compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
Measured: 24 weeks
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
Measured: 24 weeks
To compare the change in body weight at each visit
compare the change in body weight at each visit
Measured: 24 weeks
To evaluate the incidence of adverse events.
evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Chen Liu, Mackay Memorial Hospital
- Investigators
- Sung-Chen Liu, MD, Study chair, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial HospitalHui-Fang Chang, MD, Principal investigator, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branchKe-Yan Wu, MD, Principal investigator, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281605
- Sponsor's protocol ID
- 10M MHIS112
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2011
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01281605
- Acronym / sponsor ID
- 10M MHIS112
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Basal insulin, Insulin detemir, Insulin titration algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Jan 2011 (estimated)
- 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 study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.
Detailed description
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.
Inclusion criteria:
Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:
- Active titration algorithm: contact with investigator by telephone weekly.
- Usual titration algorithm: contact with investigator only at routine study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active titration algorithm | Active comparator | Behavioral: Active titration algorithmtitrate insulin dose by contacting with investigator by telephone weekly. |
| Usual titration algorithm | Experimental | Behavioral: Usual titration algorithmcontact with investigator only at routine study visit. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
Key exclusion criteria (7 listed)
- Patients with type 1 diabetes.
- Renal dialysis patients.
- History of hypoglycemia unawareness.
- Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
- Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
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 |
|---|---|---|
| Active titration algorithmAlso: Insulin detemir active titration algorithmPatients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl). | Behavioural | Active titration algorithm |
| Usual titration algorithmAlso: Insulin detemir usual titration algorithmAll patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL. | Behavioural | Usual titration algorithm |
Primary outcome
To compare the change in HbA1c between two study groups at Week 24.
Time frame: 24 weeks
compare the change in HbA1c between two study groups after 24 weeks treatment.
5 secondary outcomes
To compare the change in HbA1C between two study groups at Week 12.
Time frame: 12 weeks
To compare the proportion of patients achieving HbA1C <7% at Week 24
Time frame: 24 weeks
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
Time frame: 24 weeks
To compare the change in body weight at each visit
Time frame: 24 weeks
To evaluate the incidence of adverse events.
Time frame: 24 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 20 Aug 2018.
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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.
Sung-Chen Liu, MD study chair
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Hui-Fang Chang, MD principal investigator
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
Ke-Yan Wu, MD principal investigator
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active titration algorithm and Usual titration algorithm in people with Type 2 Diabetes, run by Mackay Memorial Hospital at 3 sites in Taiwan.
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 7 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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?
To compare the change in HbA1c between two study groups at Week 24. (time frame: 24 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 20 Aug 2018.