Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 181
- Locations
- 3
- Primary Endpoint
- To compare the change in HbA1c between two study groups at Week 24.
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- •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.
Arms & Interventions
Active titration algorithm
titrate insulin dose by contacting with investigator by telephone weekly.
Intervention: Active titration algorithm (Behavioral)
Usual titration algorithm
contact with investigator only at routine study visit.
Intervention: Usual titration algorithm (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- To compare the proportion of patients achieving HbA1C <7% at Week 24(24 weeks)
- To evaluate the incidence of adverse events.(24 weeks)
- To compare the change in HbA1C between two study groups at Week 12.(12 weeks)
- To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.(24 weeks)
- To compare the change in body weight at each visit(24 weeks)
Investigators
Sung-Chen Liu
Division of Endocrinology and Metabolism, Department of Internal Medicine
Mackay Memorial Hospital