Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes

Mackay Memorial Hospital

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Usual titration algorithm; Behavioral: Active titration algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01281605

10M MHIS112

Details and patient eligibility

About

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.

Full 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:

1. Men and women with type 2 diabetes.
2. 20 years of age.
3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
4. Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
5. 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.

Enrollment: 181 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must meet all of the following criteria:

1. Men and women with type 2 diabetes.
2. 20 years of age.
3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
4. Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
5. Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion criteria

1. Patients with type 1 diabetes.
2. Renal dialysis patients.
3. History of hypoglycemia unawareness.
4. Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
5. Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
6. Patients hypersensitive with insulin detemir or its excipients.
7. Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

Active titration algorithm

Active Comparator group

Description:

titrate insulin dose by contacting with investigator by telephone weekly.

Treatment:

Behavioral: Active titration algorithm

Usual titration algorithm

Experimental group

Description:

contact with investigator only at routine study visit.

Treatment:

Behavioral: Usual titration algorithm